Comparing F-18 FAPI PET/CT to F-18 FDG PET/CT for Metastatic Invasive Lobular Breast Cancer

This study is comparing two types of PET/CT scans, 18F-FAPI-74 PET/CT and 18F-FDG PET/CT, to see which one is better at finding tumors in people with metastatic invasive lobular breast cancer (ILC). You would receive both types of scans within a 2-week period. Researchers will compare how well each scan detects lesions and how intense the tumor signals are. They will also gather feedback from doctors and patients about the usefulness of each scan. This study is looking for 15 women, aged 18 or older, who have been diagnosed with metastatic invasive lobular breast cancer. The main goal is to see the proportion of lesions detected by the 18F-FAPI-74 PET/CT scan by the end of the study, at 1 month.

Study design
This is a pilot imaging study comparing two different PET/CT scans in 15 participants. It is a head-to-head comparison of 18F-FAPI-74 PET/CT versus 18F-FDG PET/CT.
What's involved
You would undergo both an 18F-FDG PET/CT and an 18F-FAPI-74 PET/CT scan within a 2-week period. For the 18F-FDG scan, you would fast for at least 6 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, proportion of lesions detected, is measured at the end of the study, at 1 month.

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NCT07285993

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Randy Yeh
~15 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:18F-FAPI-7418F-FDGPET/CT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of lesions detected by 18F-FAPI-74 PET/CT
Measured over End of study, at 1 month
Breast Cancer
Metastatic Invasive Lobular Breast Cancer

NCT07285993

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Randy Yeh, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

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
  • Proportion of lesions detected by 18F-FAPI-74 PET/CTEnd of study, at 1 month

    Proportion of lesions detected by 18F-FAPI-74 PET/CT but not by 18F-FDG PET/CT. All lesions will be mapped across both imaging modalities to determine whether they were detected by FAPI PET/CT but not by FDG PET/CT.