TheranosticTrials.org

Clinical Trial · NCT07899892

A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer

Overview

The purpose of this study is to find out whether it is practical (feasible) to use a new type of imaging scan called 68Ga-FAPI PET/MRI (positron emission tomography/magnetic resonance imaging) to evaluate how well breast cancer responds to neoadjuvant chemotherapy.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

Phase 1

Contacts

Somali Gavane, MD (PRINCIPAL_INVESTIGATOR)

Roberto Valentin, MD (CONTACT)

valentr2@mskcc.org

Somali Gavane, MD (CONTACT)

gavanes@mskcc.org

212-639-2403

ClinicalTrials.gov

NCT07899892

Drug / Compound

FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Lymph node metastases (either histologically confirmed or radiographic evidence of lymph node metastases).
  • Histologically confirmed, newly diagnosed invasive breast cancer
  • ECOG Performance Status of ≤ 2
  • Planned to undergo SOC NAC prior to surgical resection as outlined in section 4.1

Exclusion

  • Imaging features suspicious for concomitant in-situ cancer (LCIS/DCIS), such as nonbiopsied groups of microcalcifications
  • Severe kidney disfunction (estimated GFR \< 30 ml/min/1.73 m2) (CKD-EPI (2021))
  • Distant metastases (contraindication for NAC)
  • physical fitness not allowing scanning in prone for 30 minutes
  • Patients who cannot undergo PET/MRI scanning because of:
  • devices or implants that are not MRI safe
  • weight limits (450 lb. weight limit)
  • hypersensitivity or known allergy to gadolinium-based contrast agents
  • Pregnancy or lactation.