Status:
RECRUITING
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients di...
Eligibility Criteria
Inclusion Criteria:
- Female patient with histopathologically proven ER+ breast cancer.
- Diagnosed with locally advanced (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:
- 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
- Chronic inflammatory disease such as rheumatoid arthritis.
- Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
- Inability to provide informed consent.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06335069
Start Date
September 1 2025
End Date
March 1 2027
Last Update
September 24 2025
Active Locations (1)
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1
Maastricht University Medical Center+
Maastricht, Netherlands, 5800