Recruiting

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

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…

ClinicalTrials.gov IDNCT04861077

PhaseEARLY_PHASE1

Enrollment20

SponsorUniversity of Alabama at Birmingham

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Triple Negative Breast Cancer

About this study

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.

Primary outcomes

Baseline measure of PET standardized uptake value (SUV). (Baseline)
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. (Baseline)

Eligibility information

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

Study locations

UAB, Birmingham, Alabama 35249 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.