Status:
RECRUITING
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 patie...
Detailed 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 dete...
Eligibility Criteria
Inclusion
- Patients must be ≥ 18 years old and ≤ 75 years old
- 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
- Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
- Estimated life expectancy of greater than one year
- Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)
Exclusion
- Inability to provide informed consent F
- 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 β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 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)
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04332588
Start Date
March 25 2022
End Date
August 1 2027
Last Update
May 29 2025
Active Locations (1)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249