Status:
NOT_YET_RECRUITING
Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
EARLY_PHASE1
Brief 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 pre...
Detailed Description
Pre-study visit/Consent This visit will take about 1 hour. Participants will be asked to sign this consent form before any study procedures. Once consented, vital signs will be taken, a blood draw to...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years old and ≤ 75 years old
- Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
- \>50%Programmed death-ligand 1 (PD-L1) positive
- Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
- May not be pregnant or breastfeeding
- Subjects must be willing to sign consent
- Adequate creatinine clearance per institutional guidelines and within 30 days
- Estimated life expectancy of greater than one year
- Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)
Exclusion
- Inability to provide informed consent
- Weight over 350 lbs., due to the scanner bore size
- 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.
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
- Unable to lie still on the imaging table for one (1) hour
- contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
- Have received immunotherapy in the neoadjuvant or adjuvant setting
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04861077
Start Date
June 1 2026
End Date
August 1 2028
Last Update
July 14 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35249