Clinical Research Directory
Browse clinical research sites, groups, and studies.
Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
Sponsor: Randy Yeh
Summary
This study is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). Patients will undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT within a 2-week period (14 days + 7 days) to compare lesions, tumor detection rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective.
Official title: Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-02-16
Completion Date
2027-12-30
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
18F-FAPI-74
FAPI scans will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. Each patient will be injected intravenously with 7 mCi +/- 2 mCi of 18F-FAPI-74 followed by a 20-minute (+/-10 min) uptake period.
18F-FDG
FDG PET/CT will be performed per standard-of-care protocol at Mount Sinai Hospital. Patients will fast for at least 6 hours before FDG administration and plasma glucose levels will be checked to ensure \< 200 mg/dL. Each patient will be injected intravenously with 15 mCi +/- 20% of 18F-FDG.
PET/CT
FAPI PET/CT images will be acquired from the top of skull to mid-thigh. FDG PET/CT images will be acquired from the skull base to mid-thigh after a 60-min uptake period. Outside FDG PET/CT performed at another institutional can be accepted, if image quality and acquisition is comparable to standard-of-care protocol at Mount Sinai Hospital.
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States