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| Name | Class |
|---|---|
| Molecular Templates, Inc. | INDUSTRY |
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This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 89Zr-trastuzumab PET/CT imaging | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-trastuzumab | Drug | -To minimize uptake of the 89Zr-trastuzumab in normal tissues, immediately prior to planned 89Zr-trastuzumab injection patients will receive a 50 mg dose of "cold" unlabeled trastuzumab intravenously (IV). The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT | -SUVmax is maximum standardized uptake value | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT | At baseline | |
| Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT | At baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian A Van Tine, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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|
| Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions) | At baseline |
| ID | Term |
|---|---|
| C571668 | zirconium-89-trastuzumab |
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