Overview
Sponsor-declared trial summary
Ovarian cancer
The aim of this project is to investigate nuclear magnetic resonance (NMR)-derived metabolomics from blood samples, functional and metabolic MRI techniques and their ability to improve ovarian cancer diagnostics. Based on the above, a model able to identify ovarian cancer and improve the accuracy of correct diagnosis …
Key facts
- Sponsor
- Aarhus University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 1 Mar 2024 → ongoing
- Decision date (initial)
- 2023-12-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordic Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The aim of this project is to investigate nuclear magnetic resonance (NMR)-derived metabolomics from blood samples, functional and metabolic MRI techniques and their ability to improve ovarian cancer diagnostics.
Based on the above, a model able to identify ovarian cancer and improve the accuracy of correct diagnosis and disease severity will be proposed.
Conditions and MedDRA coding
Ovarian cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- - Suspected epithelial ovarian cancer (and referred to dept. of Gynaecology and Obstetrics, AUH)
- - Understanding Danish
- - Age 18 – 85 years
Exclusion criteria 6
- Contraindications for MRI with contrast: - eGFR less than 30 ml/min/1.73m2 - Severe unstable asthma - Pacemaker, implantable cardiac defibrillator, neurostimulator or cochlear implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Claustrophobia - Largest circumference including arms > 160 cm
- Substantial cognitive disability that would influence the patients’ ability to either give truly informed consent or listen to / comply with safety-related instructions.
- Severe renovascular disease
- Any other malign disease or recidiv of a former malign disease present within the last 3-5 years (except benign basal basocelluar carcinoma (BBC))
- Pregnancy
- Allergy to pyruvate
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- - to evaluate the diagnostic performance of DCE MRI, DKI and 31P MRS
- - to create a diagnostic algorithm that can help the clinician to classify correct diagnosis and FIGO-staging of ovarian cancer.
- - to assess if the HP 13C MRI contributes to correct histopathological diagnosis.
- - to assess if the HP 13C MRI contributes to staging of ovarian cancer.
- - For the NMR-derived analyses from the blood samples: the ability to distinguish patients with cancer from those without cancer.
- For the NMR-derived analyses from the blood samples: the prediction of correct histopathological diagnosis
Secondary endpoints 2
- - To assess the repeatability and reproducibility of multiparametric pelvic MRI in patients suspected with ovarian cancer
- For the NMR-derived analyses from the blood samples: - the prediction of surgical resectability
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hyperpolarized [1-13C]pyruvate
PRD10284730 · Product
- Active substance
- Pyruvic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.43 millilitre(s)/kilogram
- Max total dose
- 0.43 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
Dotarem, injektionsvæske, opløsning i enkeltdosisbeholder. i.v.
PRD354058 · Product
- Active substance
- Gadoteric Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.1 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA02 — GADOTERIC ACID
- Marketing authorisation
- 17091
- MA holder
- GUERBET
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University
- Sponsor organisation
- Aarhus University
- Address
- Palle Juul-Jensens Boulevard 82
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University
- Contact name
- Malene Aastrup
Public contact point
- Organisation
- Aarhus University
- Contact name
- Malene Aastrup
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-03-01 | 2024-03-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | IMPROCAS protocol | 1.3 |
| Recruitment arrangements (for publication) | Recruitment improcas | 1.1 |
| Subject information and informed consent form (for publication) | Deltagerinformation improcas | 1.2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | samtykkeerklring IMPROCAS | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-13 | Denmark | Acceptable 2023-10-04
|
2023-12-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-07 | Denmark | Acceptable 2023-10-04
|
2025-03-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-22 | Denmark | Acceptable 2025-05-28
|
2025-05-30 |