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

NCT01916135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Mark Dunphy, D.O. · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2020-04-23
Completion
2020-04-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01916135 on ClinicalTrials.gov