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

NCT04861077 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Janis O'Malley, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04861077 on ClinicalTrials.gov