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

Last updated: October 13, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma

Neoplasms

Treatment

[18F] 4-L-Fluoroglutamine (2S,4R)

Clinical Study ID

NCT01697930
12-168
  • Ages 21-90
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with history of histologically-confirmed solid malignancy and/or lymphoma (histology confirmed by MSKCC Department of Pathology.) Disease measurable orevaluable as defined by RECIST 1.1 or other tumor response criteria from an MSKCCIRB-approved clinical research protocol. NOTE: Study patients do not need to beparticipating 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 tostudy enrollment. Patients will be advised against having unprotected sexualintercourse from the time of the negative serum pregnancy test until aftercompleting their participation in the study.

Exclusion

Exclusion Criteria:

  • Inability or refusal to have at least one peripheral intravenous line forintravenous 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 toclaustrophobia)

  • 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 thenormal 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 assaysobtained <2 weeks prior to study enrollment

  • Acute major illness (e.g., unstable cardiovascular condition, etc.)

Study Design

Total Participants: 67
Treatment Group(s): 1
Primary Treatment: [18F] 4-L-Fluoroglutamine (2S,4R)
Phase: 1
Study Start date:
September 01, 2012
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

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