Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
University of Alabama at Birmingham
Summary
The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.
Description
There are 2 groups or cohorts in this study. The cohort patient's are in is based on their clinical treatment plan set by your physician. The number of imaging visits and timing of visits will be determined by what cohort they are in. If the patient is in cohort #1, they will make 4 visits to UAB. They will be scheduled for a pre-study or screening visit. During the pre-study visit, once consented, they will have a blood draw to determine kidney function, and a pregnancy test if they are a woman of childbearing potential. Their vital signs will be taken, they will be asked to fill out an MRI…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must be ≥ 18 years old and ≤ 75 years old 2. HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and/or positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility 3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment 4. Estimated life expectancy of greater than one year 5. Patients must have one lesion with RECIST m…
Interventions
- Drug[18F]FMISO PET/MRI imaging
\[18F\]FMISO PET/MRI imaging
Location
- The University of Alabama at BirminghamBirmingham, Alabama