RecruitingEarly Phase 1NCT04861077

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

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

Sponsor

University of Alabama at Birmingham

Enrollment

20 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a combination of PET and MRI scanning to monitor how well immunotherapy is working in people with triple-negative breast cancer (TNBC), a type of breast cancer that doesn't respond to hormone-based treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have biopsy-confirmed triple-negative breast cancer at stage II–IV - Your tumor tests positive for PD-L1 (a marker that suggests immunotherapy may work) - You have not yet started any immunotherapy treatment - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have already received immunotherapy - Your PD-L1 expression is below 50% - You have significant kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]FMISO-PET with contrast-enhanced MRI

Triple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle.

Locations(1)

UAB

Birmingham, Alabama, United States

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NCT04861077

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