NCT01916135

PET Imaging of Cancer Patients Using [18F]-SKI-249380, a Radiolabeled Dasatinib-Derivative

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carcinoma
• Sarcoma
• Myeloma
• Lymphoma
• Melanoma

Interventions

Type	Name	Description
RADIATION	[18F]-SKI-249380
PROCEDURE	PET/CT scan	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.
OTHER	Blood draws	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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2020-04-23
• Completion: 2020-04-23
• First posted: 2013-08-05
• Last updated: 2020-04-27

Locations

1 site across 1 country: United States