RecruitingInterventionalEarly Phase 1

PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

NCT ID: NCT03321045Sponsor: University of Alabama at BirminghamLast updated: 2026-01-26

Summary

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.

Arms & 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 TestPET/MRI Imaging
5-6 days post injection the patients will undergo PET/MRI imaging.

Outcome measures

Primary

Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with \[89Zr\]-Df-Trastuzumab in patients with newly diagnosed breast cancer.
Time frame: 24 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

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)

Study locations (1)

The Kirklin Clinic

Birmingham, Alabama, 35249

Recruiting

References

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.(PubMed)