NCT01697930

A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I study. This study is the first time that a new experimental drug called 18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its injected. PET scanners are one of the kinds of scanners you normally find in a hospital radiology department. The researchers have found that tumors in animals absorb F-Glutamine. The researchers believe that scans with F-Glutamine might be able to find tumors in patients. This first in-human study is being done to see how long F-Glutamine lasts in the blood, when it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in the body. If the results of this trial are good, then the study doctors plan to use F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors compared to the standard types of scans that doctors use.

Conditions

• Solid Malignancy
• Lymphoma

Interventions

Type	Name	Description
DRUG	[18F] 4-L-Fluoroglutamine (2S,4R)	Thirty cancer patients will receive an injection of a 0.5 to 7.5mCi of \[18F\] 4-LFluoroglutamine (2S,4R) , followed by serial PET/CT scanning and blood draws, (at the direction of the investigator) over a period of 3.5 hours, on a single day. Each patient will be offered the opportunity to repeat the \[18F\] 4-L-Fluoroglutamine (2S,4R) injection and subsequent set of post-injection PET-CT scans, once, on a separate date. At the discretion of the investigator, scan 3 can be waived. Immediately prior to injection of the radiotracer, a blood sample will be obtained for measurement of serum glutamine level. The serum glutamine level will be assayed, if necessary, as part of an amino acid screen assay.

Timeline

• Start date: 2012-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2012-10-02
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States