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

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

Recruiting
18 years and older
All
Phase 1

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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.

Eligibility

Inclusion Criteria:

  • Age ≥ 18
  • ECOG Performance Status of ≤ 2
  • Ability to review and signed informed consent
  • Histologically confirmed, newly diagnosed invasive breast cancer
  • Lymph node metastases (either histologically confirmed or radiographic evidence of lymph node metastases).
  • Planned to undergo SOC NAC prior to surgical resection as outlined in section 4.1

Exclusion Criteria:

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

Study details
    Breast Cancer
    Invasive Breast Cancer

NCT07899892

Memorial Sloan Kettering Cancer Center

31 October 2026

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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