Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [89Zr]-Df-Trastuzumab, PET/MRI Imaging.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
Overview
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.
Interventions
- Drug [89Zr]-Df-Trastuzumab
\[89Zr\]-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. - Diagnostic test PET/MRI Imaging
5-6 days post injection the patients will undergo PET/MRI imaging.
Primary outcome measures
- Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- The Kirklin Clinic — Birmingham
Publications
- Mansur A, McConathy JE, Stringer-Reasor E, Rocque G, Khoury K, Eltoum N, Nikpanah M, Bartels J, Wright B, Jahan N, Jeffers D, Lapi SE, Sorace AG. Quantitative [89Zr]Zr-Trastuzumab PET and Diffusion- Weighted MRI for Characterization of Metastatic HER2-Positive Breast Cancer with PET/MRI. J Nucl Med. 2025 Jul 1;66(7):1018-1026. doi: 10.2967/jnumed.124.268931. PMID 40473459
Identifiers
NCT: NCT03321045 · IRB-170220004 · UAB