What this study is
Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.
What's being tested
- [89Zr]-Df-Trastuzumab
Intervention · DRUG
[89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 mCi at the time of injection. The amount of injected drug is 5 mg of Trastuzumab.
- PET/MRI Imaging
Intervention · DIAGNOSTIC TEST
5-6 days post injection the patients will undergo PET/MRI imaging.
Study details
- Official title
- PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Breast Cancer
- Enrolling
- 10 people
- Starts
- 2017-11-21
- Est. completion
- 2028-10
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Be at least 18 years of age.
- Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number >= 6 OR dual probe ISH with both average HER2 copy number >= 4 AND HER2 to CEP17 ratio >=2
- Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
- Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans
You can't join if
- Inability to provide informed consent
- Pregnancy
- Inability to lie still for the imaging study
- Weight over 350 lbs., due to the scanner bore size
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Kirklin Clinic
Birmingham, Alabama, United States
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-170220004
Principal investigator
Suzanne E Lapi, PhD
University of Alabama at Birmingham
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.