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NCT01697930
A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)
Conditions: Solid Malignancy, Lymphoma
Sex: All
Ages: 21 Years – 90 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 67
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Cancer Center New York New York
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.
Eligibility Criteria
Inclusion Criteria:
* Patients with history of histologically-confirmed solid malignancy and/or lymphoma (histology confirmed by MSKCC Department of Pathology.) Disease measurable or evaluable as defined by RECIST 1.1 or other tumor response criteria from an MSKCC IRB-approved clinical research protocol. NOTE: Study patients do not need to be participating in an MSKCC approved clinical trial prior to study recruitment.
* Age between 21-90
* Negative serum pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from assays obtained \2.5 x ULN
* Albumin \< 3 g/dl
* GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN.
* Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained \
Source: ClinicalTrials.gov (NCT01697930). StuddyBuddy aggregates publicly available trial information.