Overview
Sponsor-declared trial summary
Patients with breast lesions undergoing further examination
To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer
Key facts
- Sponsor
- Istituto Europeo Di Oncologia S.r.l., Istituto Europeo Di Oncologia S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Sep 2020 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Ministero della Salute - Bando ricerca finalizzata 2021 - GR-2021-12372179
External identifiers
- EU CT number
- 2024-517486-16-00
- EudraCT number
- 2019-000326-22
- ClinicalTrials.gov
- NCT06311695
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To evaluate the role of Contrast-Enhanced Spectral Mammography in the diagnostic workup of breast cancer
Secondary objectives 1
- To evaluate CESM diagnostic performance in suspicious breast lesions
Conditions and MedDRA coding
Patients with breast lesions undergoing further examination
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Woman with suspicious breast lesions from FFDM, US and/or MR imaging and for whom a presurgical evaluation is recommended. Only women in the BI-RADS 4 radiological category risk will be included in the study.
- The subject must be in sufficient good health to be able to undergo standard of care and CESM examinations. Only patients with ECOG scale 0 or 1 performance status will be included in the study.
- Only patients with an age > or = to 18 can be included in the study.
Exclusion criteria 10
- The subject is known to have risks of adverse effects with iodine contrast agents.
- The subject is asymptomatic and without suspicious findings from routine imaging.
- The subject is participating or has participated (within the prior 30 days) in another clinical trial.
- Proved or supposed pregnancy. For all women of child bearing potential a pregnancy test will be performed before undergoing CESM.
- Patients with impairment of renal function (GFR < 30 ml/min).
- History of bronchial asthma or other allergic disorders.
- Manifest hyperthyroidism. Testing of thyroid function prior to Ultravist® administration will be performed in patients with suspected hyperthyroidism.
- Patients with risk of serious adverse reactions such as cardiac disease, heart failure, uncontrolled arterial hypertension.
- Patients in therapy with biguanide such as metformin, interleukine 2 and radioactive iodine.
- Patients with a clinical examination positive for regional lymph nodes or suspected for distant metastases (bones, brain, liver and lungs).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the negative predictive value (NPV) of CESM comparison versus the NPV of the micro-histology or final histology (after surgery)
Secondary endpoints 1
- To establish CESM diagnostic performance in suspicious breast lesions using histology from VABB as gold standard correlating the definite result (after surgery) with preoperative imaging (accuracy).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ultravist 370 mg/ml soluzione iniettabile
PRD372852 · Product
- Active substance
- Iopromide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 740 mg/kg milligram(s)/kilogram
- Max total dose
- 740 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB05 — IOPROMIDE
- Marketing authorisation
- 026965095
- MA holder
- BAYER AG
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Istituto Europeo Di Oncologia S.r.l.
- Sponsor organisation
- Istituto Europeo Di Oncologia S.r.l.
- Address
- Via Giuseppe Ripamonti 435
- City
- Milan
- Postcode
- 20141
- Country
- Italy
Scientific contact point
- Organisation
- Istituto Europeo Di Oncologia S.r.l.
- Contact name
- Enrico Cassano
Public contact point
- Organisation
- Istituto Europeo Di Oncologia S.r.l.
- Contact name
- Enrico Cassano
Istituto Europeo Di Oncologia S.r.l.
- Sponsor organisation
- Istituto Europeo Di Oncologia S.r.l.
- Address
- Via Giuseppe Ripamonti 435
- City
- Milan
- Postcode
- 20141
- Country
- Italy
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 468 | 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 |
|---|---|---|---|---|---|
| Italy | 2020-09-30 | 2020-11-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517486-16-00_Redacted | 4 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ultravist | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-19 | Italy | Acceptable 2024-10-03
|
2024-10-14 |