Using advanced PET/MRI with 18F‑FMISO to monitor immunotherapy for triple negative breast cancer

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 early-phase imaging study will enroll about 20 adults with biopsy-proven stage II–IV triple negative breast cancer who are eligible for but have not yet started immunotherapy. Participants will undergo up to three combined 18F‑FMISO PET and contrast‑enhanced MRI scans: one before starting immunotherapy and additional scans during early treatment cycles. The imaging is performed in parallel with standard oncologist-directed care and will not change treatment decisions; images and data will be analyzed to see if PET/MRI features correlate with response. If signals look promising, the results would be used to design larger trials to validate the approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must be ≥ 18 years old and ≤ 75 years old
2. Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
3. \>50%Programmed death-ligand 1 (PD-L1) positive
4. Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
5. May not be pregnant or breastfeeding
6. Subjects must be willing to sign consent
7. Adequate creatinine clearance per institutional guidelines and within 30 days
8. Estimated life expectancy of greater than one year
9. Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)

Exclusion Criteria:

1. Inability to provide informed consent
2. Weight over 350 lbs., due to the scanner bore size
3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.
4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
5. Unable to lie still on the imaging table for one (1) hour
6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
7. Have received immunotherapy in the neoadjuvant or adjuvant setting

Where it's running

• UAB
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Janis O'Malley, MD — University of Alabama at Birmingham
• Study coordinator: Sebastian Eady
• Email: smeady@uabmc.edu
• Phone: 205-996-2636

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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.