What this study is
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.
What's being tested
- 18F-FAPI-74
Intervention · DRUG
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
Intervention · DRUG
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
Intervention · PROCEDURE
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.
Study details
- Official title
- Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging
- Sponsor
- Randy Yeh
- Conditions
- Breast Cancer · Metastatic Invasive Lobular Breast Cancer
- Enrolling
- 15 people
- Starts
- 2026-06-01
- Est. completion
- 2027-12-30
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Ilda Bander · Contact(212) 241-0763Ilda.Bander@mountsinai.org
- Rashmi Unawane · Contact212-824-2385Rashmi.Unawane@mssm.edu
- Randy Yeh · Principal investigator
Study team
Sponsor
Randy Yeh
Study ID STUDY-25-00364
Principal investigator
Randy Yeh, MD
Icahn School of Medicine at Mount Sinai
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.