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Current tests to detect cancer, including CAT scans and MRI scans, are limited. PET scans use special dyes that are injected into a vein and can better localize possible cancer. The investigators have developed a new particle that can carry a radioactive dye to a very specific area of the tumor. When using a PET scan the radioactive dye can be viewed in areas of possible disease. This particle has been studied in mice and was safe.
The particles will not treat the cancer and any images or information found during this study will not be used for your treatment. The information collected may be used to guide the design of future studies to detect and/or treat tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| newly diagnosed or recurrent head/neck melanoma | Experimental | This is a two-year microdosing study that will enroll 5 metastatic melanoma patients and 18 malignant brain tumor patients (surgical (n=13) and non-surgical candidates (n=5)). We have already accrued 5 melanoma patients and expect to accrue brain tumor patients within a 1 year period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET scan with 124I-cRGDY-PEG-dots | Drug | Five (5) patients with newly diagnosed or recurrent melanoma, and 18 malignant brain tumor patients (surgical (n=13) or non-surgical candidates (n=5)). Patients with either primary or metastatic brain tumors, will be i.v. injected with approximately 5 mCi (3.4-6.7 nanomoles) of 124I-cRGDY-PEG-dots (specific activity range 750.0 - 1450 mCi/mol) and undergo the microdosing study for purposes of collecting pharmacokinetic and dosimetry data. All studies will be performed using a dedicated scanner, which integrates a dedicated PET scanner and a spiral CT with proprietary fusion software. |
| Measure | Description | Time Frame |
|---|---|---|
| Conduct pilot single-dose studies of 124I-cRGDY-PEG-dots†| in a limited number of human melanoma and brain tumor patients to characterize biodistribution, pharmacokinetics, and metabolic stability. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the radiation dosimetry of i.v.-injected 124I-cRGDY-PEG-dots. | studies have demonstrated that a dose 100 times the proposed human dose equivalent did not induce adverse effects | 1 year |
| Assay particle tracer tissue distributions in tumor tissue specimens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilda Stambuk, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25355699 | Derived | Phillips E, Penate-Medina O, Zanzonico PB, Carvajal RD, Mohan P, Ye Y, Humm J, Gonen M, Kalaigian H, Schoder H, Strauss HW, Larson SM, Wiesner U, Bradbury MS. Clinical translation of an ultrasmall inorganic optical-PET imaging nanoparticle probe. Sci Transl Med. 2014 Oct 29;6(260):260ra149. doi: 10.1126/scitranslmed.3009524. Epub 2014 Oct 29. |
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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|
| 2 years |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue 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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