Actively Recruiting
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
Led by University of Alabama at Birmingham · Updated on 2025-05-29
25
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be between 18 and 75 years old
- HER2-positive breast cancer confirmed by local pathology with IHC score 3+ or positive ISH test
- Patients with locally advanced stage II-III HER2-positive breast cancer eligible for neoadjuvant therapy and have not started treatment
- Estimated life expectancy greater than one year
- Must have at least one measurable tumor lesion greater than 1 cm in diameter
You will not qualify if you...
- Unable to provide informed consent
- Weight over 350 pounds due to scanner size limits
- Lactating, pregnant, or suspected pregnancy; women of childbearing potential must have negative pregnancy test within 48 hours before each imaging visit
- Contraindications to MRI such as non-removable metal implants or certain tattoos
- Unable to lie still on the imaging table for one hour
- Contraindications to the gadolinium-based contrast agent ProHance (gadoteridol)
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
Research Team
A
Anna Sorace, PhD
CONTACT
S
Sebastian Eady
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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