68Ga-FAPI PET/MRI imaging to see if it can track breast cancer response to chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional trial investigates the feasibility of using 68Ga-FAPI PET/MRI to monitor tumor response in adults with newly diagnosed invasive breast cancer undergoing neoadjuvant chemotherapy. Eligible participants have confirmed invasive breast cancer with lymph node involvement and are planned for standard-of-care NAC before surgery. Participants undergo the novel imaging modality in addition to standard care to assess practicality, image quality, and potential correlation with treatment response. The study is conducted at Memorial Sloan Kettering facilities in New Jersey with limited protocol activities at affiliated sites. Key safety considerations include MRI compatibility and gadolinium-related risks, with exclusions for pregnancy, severe renal impairment, and other MRI contraindications.

Why it matters

Who can join: the full rules

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)

Where it's running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited protocol activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activity)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting

Study contacts

• Principal investigator: Somali Gavane, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Somali Gavane, MD
• Email: GavaneS@mskcc.org
• Phone: 212-639-2403

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.