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

NCT07285993 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY-25-00364PRMC-25-041
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Metastatic Invasive Lobular Breast Cancer

Keywords

Breast Cancer; Novel F-18 FAPI PET; Metastatic; Invasive; Lobular; 18F-FDG PET/CT

Outcome Measures

Primary Outcomes (1)

• Proportion of lesions detected by 18F-FAPI-74 PET/CT

  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.

  End of study, at 1 month

Secondary Outcomes (7)

• Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT

  End of study, at 1 month

• Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT

  End of study, at 1 month

• Tumor detection rate

  End of study, at 1 month

• SUVmax of the hottest lesion (lesion with highest SUVmax) on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT and mean SUVmax across all lesions

  End of study, at 1 month

• Tumor-to-background ratio (TBR)

  End of study, at 1 month

Study Arms (1)

18F-FAPI-74 PET/CT and 18F-FDG PET/CT

EXPERIMENTAL

Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT.

Drug: 18F-FAPI-74; Drug: 18F-FDG; Procedure: PET/CT

Interventions

18F-FDG 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.

18F-FAPI-74 PET/CT and 18F-FDG PET/CT

PET/CT 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.

18F-FAPI-74 PET/CT and 18F-FDG PET/CT

18F-FAPI-74 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-FAPI-74 PET/CT and 18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Randy Yeh: lead
• The Society of Nuclear Medicine and Molecular Imaging: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Randy Yeh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilda Bander

CONTACT

(212) 241-0763; Ilda.Bander@mountsinai.org

Rashmi Unawane

CONTACT

(212) 824-2385; rashmi.unawane@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)