18F-FDG versus 68Ga-FAPI-46 as PET tracer in ER-positive breast cancer - a pilot study
- Conditions
- Hormone-positive breast cancerTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508066-15-00
- Lead Sponsor
- niversity Hospital Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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, 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.
Age <18., Pregnancy., Patients with secondary malignancies., 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method