Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
1,681
Countries
3
Sites
16
Long term potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group effects regarding.
To prospectively assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group.
Key facts
- Sponsor
- Iqvia Rds France
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Guerbet · Bracco Imaging S.p.A. · GE Healthcare Pharma LLC · Bayer AG
External identifiers
- EU CT number
- 2024-515462-14-00
- EudraCT number
- 2019-004730-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To prospectively assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group.
Secondary objectives 4
- To assess the change from baseline in the composite endpoints (motor and cognitive) at each of the postbaseline time points (Years 1 to 4) in GBCA-exposed participants as compared to controls.
- To assess the change from baseline for each of the individual tests (motor and cognitive) at each of the post-baseline time points (Years 1 to 5) in GBCA-exposed participants as compared to controls.
- To evaluate safety through collection of adverse events (AEs).
- To assess total gadolinium (Gd) concentrations (as measured in a central laboratory) in blood and urine samples taken from exposed and control participants at the time of annual visit.
Conditions and MedDRA coding
Long term potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group effects regarding.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Participant must be an adult having reached legal majority age and less than 65 years old.
- Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening.
- Participant agrees to be tested as per protocol for 5 consecutive years.
- Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollment and at the end of the observation period (5 years).
- Patient affiliated to national health insurance according to local regulatory requirements, where applicable.
- Participants should have at least 1 of the following indications: • Medium to high risk for breast cancer or with dense breasts undergoing breast cancer screening with magnetic resonance imaging (MRI) • Elevated prostate-specific antigen (PSA) and under active diagnostic surveillance for prostate cancer • Chronic liver disease (e.g., liver cirrhosis limited to Child class A, post-hepatitis chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of hepatocellular carcinoma (HCC) development • Low-grade colorectal cancer or neuroendocrine tumor undergoing surveillance for liver metastases • Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance
- In addition, for participants in the GBCA Arms only: Each participant should be likely to undergo ≥5 GBCA-enhanced MR examinations with the same GBCA at least annually throughout the 5-year study duration.
- In addition, for participants in the GBCA Arms only : Prospective participants with up to 3 well-documented GBCA administrations prior to study screening are acceptable, provided that the imaging was performed with the same GBCA as the one to be prospectively used in the study. If the GBCA used cannot be identified, he/she cannot be enrolled.
- For the Control Arm: Participants who never had and are not likely to receive any GBCA injection during the course of the study.
- For the Control Arm: Each control participant must be willing to undergo UE-MRI of the brain at baseline and at Year 5. In Years 1 to 4, the control participants will undergo their clinically indicated UE-MRIs, computed tomography (CT), ultrasound, or X-ray procedures.
- For the Control Arm: Participants matched with the population characteristics of the 2 GBCA study arms, including clinical indication for imaging, geographic region, and age-group. Additional potential risk factors (education level and sex) will be recorded and adjusted for as appropriate at the statistical analysis stage.
Exclusion criteria 18
- As evidenced by history or determined in the neurologic exam at screening, concurrent neurological and/or psychiatric disease (or treatments) that could influence the results of the study’s motor and cognitive tests. Examples include but are not limited to: • Cerebrovascular disease • Multiple sclerosis • Neurodegenerative disease • Malignant disease other than listed in indications • Carcinoid tumors • Epilepsy • Prior neurosurgery • Psychotic disorders or any prior psychotic episode not otherwise specified (NOS)—any documented prior history of chronic schizophrenia • Remittent or current medically confirmed major depressive disorder or bipolar disorder • History of long-term major depression or bipolar affective disorder with an active episode in the past 2 to 5 years • Neurodevelopmental disorders (e.g., trisomy 21) • Uncontrolled severe migraine • Uncontrolled or controlled anxiety or depression within 6 months before enrollment • Screening scores of ≤24 on the Mini-Mental State Examination (MMSE) and/or ≥11 on the Hospital Anxiety and Depression Scale (HADS)
- Prior, planned, or ongoing chemotherapy or brain irradiation.
- Use of concomitant medication (CM)(s) affecting neuro-cognitive or motor function (an authorized exception is a single intake before the study MRI because of anxiety if administered after the motor and cognitive test evaluation): • Regular use of benzodiazepines or non-benzodiazepine hypnotics. Long-acting benzodiazepines (e.g., diazepam) should not be administered within 24 hours prior to cognitive testing. • Short/medium-acting benzodiazepines (e.g., alprazolam, lorazepam, oxazepam, temazepam), except if used chronically for sleep and on a stable dose for 8 weeks prior to Screening Visit 1 or 12 hours prior to cognitive testing • Regular use of anticholinergic drugs (anticholinergics for bladder control with limited cognitive effects are permitted) • Long-term use of corticosteroids or methotrexate, cladribine • Regular use of antidepressants (e.g., anticholinergic, tricyclic, monoamine oxidase inhibitors (MAOIs), norepinephrine–dopamine reuptake inhibitors (NDRIs) selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or lithium, antiepileptics and/or antipsychotic drugs: Use of antidepressants is allowed if at stable doses for 8 weeks prior to Screening Visit. Antipsychotics used on a regular basis, except for low doses of atypical antipsychotics (e.g., risperidone, aripiprazole, or quetiapine), anticonvulsants with limited cognitive effects, such as lamotrigine, pregabalin, levetiracetam for treatment of pain, and other non-epilepsy indications, are allowed as-needed basis or if used at a stable dose for 8 weeks prior to Screening Visit • CNS stimulants (e.g., for attention-deficit/hyperactivity disorder [ADHD])
- Substance or alcohol abuse as determined by the investigator.
- Alcoholic cirrhosis.
- Any history or presence of other relevant chronic disease that prevents participation in the study or that may confound neurofunction testing.
- Renal disease, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, calculated by using the Modification of Diet in Renal Disease (MDRD) formula or the Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- History of environmental/occupational/other exposure to one or more chemicals that may affect cognitive and/or motor function, including, but not limited to, heavy metals (arsenic [As], cadmium [Cd], lead [Pb], manganese [Mn], and mercury [Hg]), pesticides, solvents, or carbon monoxide.
- Anticipated, current, or past conditions (medical, psychological, social, or geographical) that, in the opinion of the investigator, would compromise the participant’s safety or her/his ability to participate in the study (e.g., clinically significant vitamin B12 deficiency, folic acid deficiency, uncontrolled thyroid dysfunction from medical history).
- Clinical indications requiring >1 contrast-enhanced magnetic resonance imaging (CE-MRI) every 6 months.
- Receipt of any investigational product or participation in any other clinical trial within 30 days prior to enrolling in this study or while enrolled in this trial.
- Previous enrollment in this study.
- Pregnant or nursing (lactating) women.
- Presence of any metal-containing joint implants/prostheses.
- In addition, for participants in either of the GBCA Arms only: Any contraindication to GBCA-enhanced MRI examinations.
- In addition, for participants in either of the GBCA Arms only: Receipt of a GBCA or generic prior to study entry other than the specific GBCA to be administered during the course of the study.
- In addition, for participants in the Control Arm only: Participants with any previous exposure to a GBCA.
- In addition, for participants in the Control Arm only: Participants with any contraindication to UE-MRI examinations.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The co-primary endpoints are the change from baseline to Year 5 in motor function and in cognitive function as expressed by the composite z score, defined as the weighted sum of the z scores of the individual tests. Since each of these tests is considered equally important, each test will be assigned an equal weight.
Secondary endpoints 3
- Changes from baseline in the composite endpoint (Years 1 to 4) and in each individual test of motor and cognitive function (Years 1 to 5) will be assessed.
- Evaluation of AEs. The recording of AEs that occur after signing of the informed consent form (ICF) at Screening, will be done at baseline and at each annual visit. Signs/symptoms, onset date/time, severity, causality, seriousness, treatment and outcome will be recorded.
- Total gadolinium concentrations in blood plasma and urine samples collected at baseline and at each annual visit will be determined. If the CE-MRI is obtained at the same visit, the blood and urine samples will be obtained prior to imaging.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 26
SUB39501 · Substance
- Active substance
- Gadoxetic Acid, Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 millilitre(s)/kilogram
- Max total dose
- 0.1
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB39501 · Substance
- Active substance
- Gadoxetic Acid, Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 millilitre(s)/kilogram
- Max total dose
- 0.1
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB39501 · Substance
- Active substance
- Gadoxetic Acid, Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 millilitre(s)/kilogram
- Max total dose
- 0.1
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07865MIG · Substance
- Active substance
- Gadoteric Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.1
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07865MIG · Substance
- Active substance
- Gadoteric Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1
- Max total dose
- 0.1
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07861MIG · Substance
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.5 mmol/kg millimole(s)/kilogram
- Max total dose
- 1.5
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07861MIG · Substance
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.5 mmol/kg millimole(s)/kilogram
- Max total dose
- 1.5
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07861MIG · Substance
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.5 mmol/kg millimole(s)/kilogram
- Max total dose
- 1.5
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07861MIG · Substance
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.5 mmol/kg millimole(s)/kilogram
- Max total dose
- 1.5
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07861MIG · Substance
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.5 mmol/kg millimole(s)/kilogram
- Max total dose
- 1.5
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07861MIG · Substance
- Active substance
- Gadobutrol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.5 mmol/kg millimole(s)/kilogram
- Max total dose
- 1.5
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07866MIG · Substance
- Active substance
- Gadoteridol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.3 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.3
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20638 · Substance
- Active substance
- Gadobenate Dimeglumine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.05 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.05
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Iqvia Rds France
- Sponsor organisation
- Iqvia Rds France
- Address
- 17 Place Des Reflets
- City
- Courbevoie
- Postcode
- 92400
- Country
- France
Scientific contact point
- Organisation
- Iqvia Rds France
- Contact name
- Alexander Kostylev
Public contact point
- Organisation
- Iqvia Rds France
- Contact name
- Alexander Kostylev
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8, Code 9 |
Locations
3 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 284 | 1 |
| Germany | Authorised, recruitment pending | 271 | 5 |
| Italy | Authorised, recruitment pending | 162 | 10 |
| Rest of world
Russian Federation, Korea, Republic of, Brazil, United States
|
— | 964 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Département de Radiologie 1, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
University Hospital Cologne AöR
Institut und Poliklinik fuer Radiolog. Diagnostik (Radiology), Kerpener Strasse 62, Lindenthal, Cologne
Vivantes Netzwerk fuer Gesundheit GmbH
Radiologie und interventionelle Therapie ( Radiology and Interventional Therapy), Rudower Strasse 48, Buckow, Berlin
Klinikum der Universitaet Muenchen AöR
Department of Radiology, Marchioninistrasse 15, Hadern, Munich
Goethe University Frankfurt
Diagnostische und Interventionelle Radiologie (Institue of Radiology and Nuclear Medicine), Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Tuebingen AöR
Diagnostische und Interventionelle Radiologie (Department of Radiology), Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Ospedale San Raffaele S.r.l.
Unità di Radiologia Diagnostica, Via Olgettina 60, 20132, Milan
Azienda USL IRCCS Di Reggio Emilia
Oncology Service, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliera di Padova
Multivisceral Transplant Unit, Via Nicolo' Giustiniani 2, 35128, Padova
Universita' Degli Studi Di Ferrara
University Radiology, Via Aldo Moro 8, 44124, Ferrara
Azienda Ospedaliera Universitaria Senese
Dipartimento di Scienze Neurologiche e Motorie, UOC Neuroimmagini, Viale Mario Bracci 1, 53100, Siena
Ospedale San Raffaele S.r.l.
Unità di radiologia a indirizzo senologico, Via Olgettina 60, 20132, Milan
Universita' Campus Bio-medico Di Roma
DIAGNOSTICS BY IMAGING, Via Alvaro Del Portillo 21, 00128, Rome
Azienda Ospedaliera Universitaria Integrata Verona
Radiology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Istituto Europeo Di Oncologia S.r.l.
Divisione di Radiologia Senologica Dipartimento di Immagini e Scienze Radiologiche, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Sanitaria Universitaria Giuliano Isontina
Oncology, Via Costantino Costantinides 2, 34128, Trieste
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol Clarification Letter_1 ENG EU 2024-515462-14-00 | N/A |
| Protocol (for publication) | D1_ Protocol Clarification Letter_2_ENG EU CT 2024-515462-14-00 | N/A |
| Protocol (for publication) | D1_ Protocol Clarification Letter_3_ENG EU CT 2024-515462-14-00 | N/A |
| Protocol (for publication) | D1_ Protocol Clarification Letter_4-ENG EU CT 2024-515462-14-00 | N/A |
| Protocol (for publication) | D1_ Protocol EU CT 2024-515462-14-00 _redacted | 1 |
| Protocol (for publication) | D1_Protocol amendment letter_redacted_ENG EU CT 2024-515462-14-00 | NA |
| Recruitment arrangements (for publication) | CTIS placeholder for transitional trial | 1 |
| Recruitment arrangements (for publication) | CTIS placeholder for transitional trial | 1 |
| Recruitment arrangements (for publication) | CTIS placeholder for transitional trial | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Country Main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Country Main_DE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Information Notice and Consent to Process Personal Data_Redacted | 1.0.a |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Main_Redacted | 1.0.a |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC DOTAREM | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Gadovist solution for injection | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Gadovist-prefilled syringes cartridges | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Primovist for injection | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Primovist pre-filled syringe | NA |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG EU CT 2024-515462-14-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FRA EU CT 2024-515462-14-00 | AMD 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ITA EU CT 2024-515462-14-00 | AMD 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-17 | France | Acceptable 2024-11-27
|
2024-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-22 | France | Acceptable 2026-04-14
|
2026-04-15 |