Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Baseline measure of PET standardized uptake value (SUV).
Study Overview
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 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.
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 determine kidney function, and a pregnancy test will be performed for women of childbearing potential. Participants will be asked to fill out an MRI questionnaire and they will be given an additional information sheet on the gadolinium-based contrast agent, Prohance, that the FDA requires for all patients receiving this type of drug. Because the PET/MRI is smaller than most MRI scanners, participants will have a PET/MRI fit test to ensure a proper fit. If eligible for this study, participants will be scheduled for the first PET imaging visit which will occur before they start immunotherapy.
Imaging visits
During this study participants will be scheduled for up to 3 imaging visits. The first imaging visit must be performed before participants start immunotherapy and is necessary for remaining eligible for this study. If, for some reason, the participant misses the following (i.e, 2nd) scheduled imaging visit, they are still eligible to continue in this study as long as they can complete a second imaging visit after finishing the 1st cycle of immunotherapy and before starting the 4th cycle of immunotherapy.
Imaging Visit #1
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR)
The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 millicuries (mCi)/10milliliters (mL) [18F]FMISO (≤ 15 µg/injected dose) followed by an uptake of 120 minutes.
The injection will be infused nominally over one minute followed by a saline flush. After uptake, the patient will be scanned on the PET/MR for 60 minutes and will receive a contrast injection of gadoteridol during the dynamic sequence of the exam. The patient can be scanned on the PET/CT if the PET/MR is unavailable. During this study patients will be scheduled for up to 3 imaging visits. The first imaging visit will be at baseline prior to starting immunotherapy and is required for study eligibility. If for some reason the patient cannot complete the remaining 2 imaging visits, only one additional imaging visit during the identified times is necessary to remain eligible.
Intervention: [18F]FMISO-PET with contrast-enhanced MRI (Drug)
Outcomes
Primary Outcomes
Baseline measure of PET standardized uptake value (SUV).
Time Frame: Baseline
Compare baseline metrics from PET/MRI
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Time Frame: Baseline
Compare baseline metrics from PET/MRI.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anna G. Sorace
Associate Professor
University of Alabama at Birmingham