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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
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 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.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
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.
Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
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.
Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, 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.
Time frame: 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.
Time frame: approximately 1, 5, 15, 30, and 90 minutes and 3 hours, post-injection
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