Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
30
Countries
1
Sites
1
Breast cancer
To investigate the correlation between gadopiclenol-enhanced multiparametric magnetic resonance imaging findings with histopathological results from breast cancer surgery.
Key facts
- Sponsor
- Fundacion Ribera Salud
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 22 Sep 2025 → 19 Feb 2026
- Decision date (initial)
- 2025-09-05
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Laboratorio Farmaceuticos Guerbet
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety
To investigate the correlation between gadopiclenol-enhanced multiparametric magnetic resonance imaging findings with histopathological results from breast cancer surgery.
Secondary objectives 3
- Ability to detect and characterize multiple lesions within the same breast.
- Evaluate the effect of gadopiclenol on Background Parenchymal Enhancement (BPE) patterns and how BPE impacts lesion visibility.
- Assess the safety profile of gadopiclenol.
Conditions and MedDRA coding
Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10057654 | Breast cancer female | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | GAPI-PRIME Prospective, open, single-center, low interventional pilot study to explore the diagnosis value of the gadopiclenol in mpMRI in BrCa. The recruitment period will last 3 months to enrol 30 patients approximately from the Hospital Vinalopó. The expected duration of each patient in the study is about 7 weeks from the date of inform consent signature.
|
Not Applicable | None | GADOPICLENOL: Gadopiclenol will be administered intravenously. The contrast agent will be delivered via a single bolus injection with the use of a power injector. To ensure proper distribution and optimal imaging conditions. Following the contrast agent injection, a saline flush will be administered at the same rate to ensure the complete delivery of the contrast agent into the circulation. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Female patients ≥ 18 years old with confirmed diagnosis of breast cancer by core needle biopsy or highly suspicious based on previous imaging examination (BI-RADS 4C-5).
- Patients who give written informed consent prior to their inclusion in the study.
- The patients must be scheduled for preoperative multiparametric magnetic resonance imaging as part of their standard diagnostic workup and for surgical resection of the tumor, with available histopathological data post-surgery.
Exclusion criteria 5
- Patients with prior breast cancer or breast surgery, including excisional biopsy.
- Patients that have received neoadjuvant chemotherapy before undergoing magnetic resonance imaging.
- Patients who are pregnant or breastfeeding, as well as those with contraindications to magnetic resonance imaging, such as metallic implants or pacemakers.
- Patients with severe renal impairment, defined by an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m² due to the risks associated with gadolinium-based contrast agents.
- Patients with known allergic reactions to gadolinium-containing contrast agents, including gadopiclenol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evaluate the correlation between the multiparametric magnetic resonance imaging lesion characteristics (size, type of lesion, morphology, enhancement pattern and kinetics, laterality and location of primary tumor) and histopathological tumor parameters (size, grade, histological type, lymph node status, lymphovascular invasion, nodal metastases and molecular subtype).
Secondary endpoints 3
- Diagnostic accuracy of gadopiclenol in detecting and characterizing multiplicity of breast cancer lesions.
- Assessment of BPE patterns (minimal, mild, moderate and marked) and their influence on lesion visibility.
- Assessment of the safety profile by collecting the adverse events during the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Elucirem 0.5 mmol/mL solution for injection
PRD11007476 · Product
- Active substance
- Gadopiclenol
- Substance synonyms
- P-03277, P03277
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.5 mmol/ml millimole(s)/millilitre
- Max total dose
- 0.5 mmol/ml millimole(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA12 — -
- Marketing authorisation
- EU/1/23/1772/025
- MA holder
- GUERBET
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Ribera Salud
- Sponsor organisation
- Fundacion Ribera Salud
- Address
- Calle De Serrano 45
- City
- Madrid
- Postcode
- 28001
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Ribera Salud
- Contact name
- Research Program Manager
Public contact point
- Organisation
- Fundacion Ribera Salud
- Contact name
- Research Program Manager
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Adknoma Health Research S.L. ORG-100045788
|
Madrid, Spain | On site monitoring, Code 10, Code 12, Code 5, Data management |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 30 | 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 |
|---|---|---|---|---|---|
| Spain | 2025-09-22 | 2026-02-19 | 2025-10-07 | 2025-12-22 |
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 2025-521810-24-00_Cegado | 03-00 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 02-00 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cegado | 02-00 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Elucirem | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2025-521810-24-00_Cegado | 03-00 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2025-521810-24-00_Cegado | 03-00 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-09 | Spain | Acceptable 2025-09-02
|
2025-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-08 | Spain | Acceptable 2026-02-14
|
2026-02-18 |