Overview
Sponsor-declared trial summary
Breast Cancer
To evaluate whether AI-enhanced low-dose gadolinium contrast-enhanced breast MRI achieves diagnostic image quality equivalent to standard-of-care-dose breast MRI
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Aug 2025 → ongoing
- Decision date (initial)
- 2025-02-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- European Research Council (ERC)-SAFE-MRI Project
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To evaluate whether AI-enhanced low-dose gadolinium contrast-enhanced breast MRI achieves diagnostic image quality equivalent to standard-of-care-dose breast MRI
Secondary objectives 1
- Diagnostic performance
Conditions and MedDRA coding
Breast Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult women ( > 18 years old) that are scheduled to undergo contrast-enhanced breast MRI
Exclusion criteria 9
- Women under 18 years old
- Individuals not scheduled for contrast-enhanced breast MRI
- Pregnant or breastfeeding women
- Individuals with contraindications to MRI (e.g., pacemakers, metal implants) and claustrophobia
- Patients with renal insufficiency (eGFR < 30 ml/min/1.73m2)
- Patients on hemodialysis or peritoneal dialysis
- Patients with known allergic reactions to GBCAs
- Male subjects
- Women who cannot give informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Qualitative Evaluation of image quality
- Quantitative Evaluation of image quality
Secondary endpoints 1
- Diagnostic performance
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
DOTAREM 0,5 mmol/ml oplossing voor injectie in injectieflacons.
PRD6751556 · Product
- Active substance
- Gadoteric Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 10 mmol/kg millimole(s)/kilogram
- Max total dose
- 10 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA02 — GADOTERIC ACID
- Marketing authorisation
- RVG 14203
- MA holder
- GUERBET
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Stichting Radboud University Medical Center
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Stichting Radboud University Medical Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 100 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2025-08-14 | 2025-08-14 |
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) | D1_Protocol_EU_CT_024_518549_27_00 | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment procedure EU CT 2024-518549-27-00 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_EU CT 2024-518549-27-00 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Dotarem_NL | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis_EU CT 2024-518549-27-00 Dutch | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU_CT_2024_518549_27_00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-21 | Netherlands | Acceptable 2025-02-20
|
2025-02-20 |