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RecruitingPhase 1

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

A Prospective Study to Evaluate the Feasibility of 68Ga-FAPI Breast PET/MRI in Diagnosing a Breast Cancer Pathologic Complete Response Following Neoadjuvant Chemotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (8)

NJ

NY