18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Maastricht University Medical Center+
RECRUITING
Maastricht
Contact Information
Primary
Thiemo JA van Nijnatten, MD, PhD
thiemo.nijnatten@mumc.nl
+31433876910
Backup
Lisa EHW Duijx, MSc
lisa.duijx@mumc.nl
+31639289798
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 20
Treatments
Experimental: Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam
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.
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov