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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Apr 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a special imaging technique called PET/MRI can help monitor the effects of immunotherapy in women with triple negative breast cancer, which is a more challenging type of cancer. The researchers want to see if a specific imaging agent, called FMISO, can predict how well immunotherapy will work for patients in stages II to IV of the disease. It's important to know that this trial is not changing any patient's treatment plan; it's simply gathering information that could help design larger studies in the future.

To be eligible for this trial, participants must be women aged 18 to 75 who have been diagnosed with triple negative breast cancer and have certain test results showing they are suitable for immunotherapy. They should not have received any immunotherapy treatments before. Participants will undergo imaging tests but will continue with their regular cancer treatment as directed by their doctors. The trial is not yet recruiting, so interested patients should check back for updates on when they can join.

Gender

FEMALE

Eligibility 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