18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
- Conditions
- Breast NeoplasmsBreast CancerBreast Diseases
- Interventions
- Diagnostic Test: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI
- Registration Number
- NCT06335069
- Lead Sponsor
- Maastricht University Medical Center
- 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 diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- 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
- Chronic inflammatory disease such as rheumatoid arthritis.
- Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
- Inability to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.
- Primary Outcome Measures
Name Time Method To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer. Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed. The feasibility of using 68Ga-FAPI-46 as a tracer in terms of diagnostic accuracy will be compared per patient with 18F-FDG as a PET tracer.
- Secondary Outcome Measures
Name Time Method To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI. Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed. Diagnostic performance will be compared between both exams (i.e. 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI.
Trial Locations
- Locations (1)
Maastricht University Medical Center+
🇳🇱Maastricht, Netherlands