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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB Department of Radiology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [89Zr]-Df-Trastuzumab | Experimental | [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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [89Zr]-Df-Trastuzumab | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denise Jeffers, PharmD | Contact | 205-975-6469 | charlottejeffers@uabmc.edu | |
| Sebastian Eady, BS | Contact | 2059962636 | smeady@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Suzanne E Lapi, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic | Recruiting | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40473459 | Derived | 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. |
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| PET/MRI Imaging | Diagnostic Test | 5-6 days post injection the patients will undergo PET/MRI imaging. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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