Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET

Randy Yeh

Status and phase

Not yet enrolling

Phase 2

Conditions

Breast Cancer

Metastatic Invasive Lobular Breast Cancer

Treatments

Drug: 18F-FDG

Drug: 18F-FAPI-74

Procedure: PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT07285993

STUDY-25-00364

PRMC-25-041 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
Females; Age > 18 years of age
Diagnosis of invasive lobular breast cancer, with pathologically confirmed metastatic disease.
ECOG performance status 0-2
No planned change in anticancer therapy between FDG and FAPI PET scans

Exclusion criteria

Patients who are pregnant or lactating
Patients who cannot undergo PET/CT scanning
Patients with total serum bilirubin or serum creatinine > 1.5 times the upper limit of normal