Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT04861077|
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer Stage II-IV||Drug: [18F]FMISO-PET with contrast-enhanced MRI||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study|
|Estimated Study Start Date :||August 2, 2021|
|Estimated Primary Completion Date :||August 2, 2026|
|Estimated Study Completion Date :||August 2, 2027|
Experimental: Breast [18F]FMISO-PET with contrast-enhanced MRI
The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 mCi/10mL [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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861077
|Contact: Sebastian Eadyemail@example.com|
|United States, Alabama|
|Birmingham, Alabama, United States, 35249|
|Contact: Sebastian Eady 205-966-2636 firstname.lastname@example.org|
|Principal Investigator:||Janis O'Malley, MD||University of Alabama at Birmingham|