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The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptinâ„¢). By giving you this tracer after you have treatment with trastuzumab (Herceptinâ„¢), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies. |
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| 2 | Experimental | breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET Imaging With Cu-64 Labeled Trastuzumab | Radiation | The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab | conclusion of study |
| Measure | Description | Time Frame |
|---|---|---|
| to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer. | conclusion of study | |
| to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Carrasquillo, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| PET Imaging With Cu-64 Labeled Trastuzumab | Radiation | The remaining 20 patients will undergo one PET study. |
|
| conclusion of study |
| D017437 |
| Skin and Connective Tissue Diseases |