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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    85
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 30 June 2022
cancer
lymphoma

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.

Details
Condition Solid Malignancy, Lymphoma
Treatment [18F] 4-L-Fluoroglutamine (2S,4R)
Clinical Study IdentifierNCT01697930
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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 weeks prior to study enrollment. Patients will be advised against having unprotected sexual intercourse from the time of the negative serum pregnancy test until after completing their participation in the study

Exclusion Criteria

Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [18F] 4-L-Fluoroglutamine (2S,4R) injection and blood draws.)
Breast-feeding
Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
Hepatic: from assays obtained <2 weeks prior to study enrollment For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay
Bilirubin > 1.5 x (ULN)
AST/ALT >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 <2 weeks prior to study enrollment
Acute major illness (e.g., unstable cardiovascular condition, etc.)
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