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This study is the first time that a new experimental drug called [18F]-SKI-249380 is being used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find tumors in patients.
This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is given to people in tiny amounts by an injection into a vein in their arm, and to see where [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380 are better for finding tumors compared to the standard types of scans that doctors use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]-SKI- 249380 and PET/CT scanning | Experimental | Patients will receive an injection of up to 7.5 (0.5-7.5) mCi of [18F]-SKI- 249380, followed by serial PET/CT scanning and blood draws, over a period of 3.5 hours, on a single day. PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. Each patient will be offered the opportunity to repeat the 18F-SKI-249380 injection and subsequent set of post-injection PET-CT scans, once, on a separate date. Each patient may or may not be receiving treatment with dasatinib therapy at the time of 18F-SKI-249380 PET, for their first PET study, as well as repeat PET study, at the discretion of their oncologist according to best clinical judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-SKI-249380 | Radiation |
| ||
| PET/CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed. | approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| metabolism | This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed. | approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection |
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Inclusion Criteria:
Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm.
Histology confirmed by MSKCC Department of Pathology.
Disease that is either:
Age between 21-90
Negative serum pregnancy test for females of child-bearing age (11-55 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy.)
Not breast-feeding, if applicable.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Dunphy, D.O. | 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 |
|---|---|
| D002277 | Carcinoma |
| D012509 | Sarcoma |
| D054219 | Neoplasms, Plasma Cell |
| D008223 | Lymphoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Procedure |
PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. This includes an initial 30-minute PET scanning period, performed. At each subsequent time-point, a 30 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A 30-45 minute scanning time-period is typical for clinical PET studies. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. |
|
| Blood draws | Other | Blood will be drawn at the multiple time points for pharmacokinetic & metabolite analyses of 18F-SKI-249380. We anticipate these time points to be approximately 1, 5, 15, 30, and 90 minutes and 3 hours (optional), post-injection. |
|
| biodistribution |
This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed. |
| approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection |
| radiation dosimetry | This will be evaluated by non-invasive blood- and PET-based assays, at multiple time points. Blood/plasma assayed by standard radio-HPLC and/or TCA methods for quantitating activity, metabolites, and plasma protein binding will be performed. | approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |