Using advanced PET/MRI with 18F‑FMISO to monitor immunotherapy for triple negative breast cancer
Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
This project will test whether a special PET/MRI scan with 18F‑FMISO can show and help predict how immunotherapy is working in people with PD‑L1 positive triple negative breast cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04861077 on ClinicalTrials.gov |
What this trial studies
This early-phase imaging study will enroll about 20 adults with biopsy-proven stage II–IV triple negative breast cancer who are eligible for but have not yet started immunotherapy. Participants will undergo up to three combined 18F‑FMISO PET and contrast‑enhanced MRI scans: one before starting immunotherapy and additional scans during early treatment cycles. The imaging is performed in parallel with standard oncologist-directed care and will not change treatment decisions; images and data will be analyzed to see if PET/MRI features correlate with response. If signals look promising, the results would be used to design larger trials to validate the approach.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 years old with biopsy‑proven stage II–IV triple negative breast cancer, PD‑L1 positive (≥50%), eligible for immunotherapy but not yet started, with at least one RECIST‑measurable lesion >1 cm and adequate kidney function.
Not a fit: Patients already receiving immunotherapy, with low or unknown PD‑L1 expression, who are pregnant or breastfeeding, who exceed the scanner weight/fit limits, or who have a life expectancy under one year are unlikely to benefit from joining this imaging study.
Why it matters
Potential benefit: If successful, this approach could let doctors detect whether immunotherapy is working earlier and help personalize treatment for patients with triple negative breast cancer.
How similar studies have performed: Related PET imaging approaches have shown promise for monitoring therapy in other cancers, but using 18F‑FMISO PET/MRI specifically to predict immunotherapy response in triple negative breast cancer is relatively novel and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- UAB — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Janis O'Malley, MD — University of Alabama at Birmingham
- Study coordinator: Sebastian Eady
- Email: smeady@uabmc.edu
- Phone: 205-996-2636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.