Overview
Sponsor-declared trial summary
Hormone-positive breast cancer
The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET-tracer in patients with ER+ breast cancer.
Key facts
- Sponsor
- University Hospital Maastricht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Sep 2025 → ongoing
- Decision date (initial)
- 2025-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508066-15-01
- ClinicalTrials.gov
- NCT06335069
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Diagnosis
The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET-tracer in patients with ER+ breast cancer.
Secondary objectives 1
- To explore the feasibility of taking biopsies in test-positive patients.
Conditions and MedDRA coding
Hormone-positive breast cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-508066-15-00 | 18F-FDG versus 68Ga-FAPI-46 as PET tracer in ER-positive breast cancer - a pilot study | University Hospital Maastricht |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Female patient with histopathologically proven ER+ breast cancer.
- Diagnosed with locally advanced breast cancer (primary tumor >5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.
- Willing and able to undergo the study procedures.
- Has personally provided written informed consent.
Exclusion criteria 8
- Age <18.
- Pregnancy.
- Patients with secondary malignancies (except non-melanoma skin cancer).
- No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.
- Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity
- Inability to provide informed consent.
- Chronic inflammatory disease such as rheumatoid arthritis.
- Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of discordant pairs: How many lesions are detected on the 68Ga-FAPI-46 PET scan but not on the 18F-FDG PET scan and how many lesions are detected on the 18F-FDG PET scan but not on the 68Ga-FAPI-46 PET scan?
Secondary endpoints 1
- To investigate the proportion of 68Ga-FAPI-46-positive 18F-FDG-negative lesions for which performing a biopsy is not feasible.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11117979 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 3 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 495 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY HOSPITAL MAASTRICHT
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Steripet 250 MBq/ml Oplossing voor injectie
PRD1823760 · Product
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 450 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 450 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- RVG 33033
- MA holder
- GE HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Maastricht
- Sponsor organisation
- University Hospital Maastricht
- Address
- P Debyelaan 25
- City
- Maastricht
- Postcode
- 6229 HX
- Country
- Netherlands
Scientific contact point
- Organisation
- University Hospital Maastricht
- Contact name
- T.J.A. van Nijnatten
Public contact point
- Organisation
- University Hospital Maastricht
- Contact name
- T.J.A. van Nijnatten
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 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 | 2025-09-01 | 2025-12-02 |
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 2023-508066-15-01_redacted | 7 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC 18F-FDG | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG 2023-508066-15-01 | 4 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL 2023-508066-15-01 | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-15 | Netherlands | Acceptable with conditions 2025-03-17
|
2025-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-01 | Netherlands | Acceptable 2025-06-23
|
2025-06-23 |