Clinical trial · Interventional
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [89Zr]-Df-Trastuzumab | Drug | — | UNRESOLVED |
| PET/MRI Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [89Zr]-Df-Trastuzumab
- description
- \[89Zr\]-Df-Trastuzumab \[89Zr\]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 millicurie (mCi) at the time of injection. The amount of injected drug is 5 mg of Trastuzumab. 5-6 days post injection the patients will undergo PET/MRI imaging.
- interventionNames
- Drug: [89Zr]-Df-Trastuzumab
- Diagnostic Test: PET/MRI Imaging
Primary outcomes (1)
- measure
- Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
- timeFrame
- 24 months
- description
- To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with \[89Zr\]-Df-Trastuzumab in patients with newly diagnosed breast cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDMansur 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