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OncoMatch/Clinical Trials/NCT04861077

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

Is NCT04861077 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies [18F]FMISO-PET with contrast-enhanced MRI for triple negative breast cancer.

Early Phase 1RecruitingUniversity of Alabama at BirminghamNCT04861077Data as of May 2026

Treatment: [18F]FMISO-PET with contrast-enhanced MRIThis 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.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) (>50%)

>50%Programmed death-ligand 1 (PD-L1) positive

Disease stage

Required: Stage II, III, IV

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: immunotherapy

Have received immunotherapy in the neoadjuvant or adjuvant setting

Lab requirements

Kidney function

adequate creatinine clearance per institutional guidelines and within 30 days

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UAB · Birmingham, Alabama

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