Recruiting
Phase 1

68Ga-FAPI PET/MRI

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07899892

Conditions

Breast Cancer

Invasive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

68Ga-FAPI-PET/MRI

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Invasive Breast Cancer

Study ID

NCT07899892

Start date

Oct 20, 2026

Status verified date

Oct, 2026

Completion date

Oct 20, 2028

Anticipated

Primary completion date

Oct 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Participants with Breast Cancer

Participants with histologically confirmed, newly diagnosed invasive breast cancer

Interventions

68Ga-FAPI-PET/MRI

68Ga-FAPI-PET/MRI is conducted 3 times in every participant.

Primary outcome measure

  • Number of participants able to complete all 3 planned scans [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Somali Gavane, MD

212-639-2403GavaneS@mskcc.org

Roberto Valentin, MD

ValentR2@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Somali Gavane, MD

212-639-2403

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Somali Gavane, MD

212-639-2403

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Somali Gavane, MD

212-639-2403

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Simone Gavane, MD

212-639-2403

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activity)

Recruiting

Commack, New York, United States, 11725

Contacts

Somali Gavane, MD

212-639-2403

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Simone Gavane, MD

212-639-2403

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Somali Gavane, MD

212-639-2403

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Simone Gavane, MD

212-639-2403

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • Breast Cancer
  • Invasive Breast Cancer
  • 68Ga-FAPI
  • Memorial Sloan Kettering Cancer Center
  • 26-320

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.