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Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

RecruitingEarly phase 1

Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study

Who can join

Ages 18 to 75 · Women

Full eligibility criteria
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

About the study

This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.

What is being tested

Sponsor: University of Alabama at Birmingham · Participants: 20 · Started: 2027-06

Contact the study team

Official record on ClinicalTrials.gov — NCT04861077

Locations in the U.S.

AlabamaUAB, Birmingham

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.