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

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Sep 2025 to Sep 2026v30
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 85 to confirmed 67
    • Site details revised
    v29
  4. 2 versions Re-verified since Aug 9, 2024, no change to tracked fieldsv27-v28
  5. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 66 to 85
    • Site details revised
    v26
Show 24 earlier versionsHide 24 earlier versions
  1. Primary and study completion dates: Sep 2024 to Sep 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 85 to confirmed 66
    • Site details revised
    v25
  2. 3 versions Re-verified since Jun 15, 2022, no change to tracked fieldsv22-v24
  3. Primary and study completion dates: Sep 2022 to Sep 2024v21
  4. Re-verified, no change to tracked fieldsv20
  5. Primary and study completion dates: Sep 2021 to Sep 2022v19
  6. Enrollment target: 65 to 85v18
  7. Primary and study completion dates: Sep 2020 to Sep 2021v17
  8. Primary and study completion dates: Sep 2019 to Sep 2020v16
  9. Primary and study completion dates: Sep 2018 to Sep 2019v15
  10. Primary and study completion dates: Sep 2017 to Sep 2018v14
  11. Enrollment target: 50 to 65v13
  12. Primary and study completion dates: Sep 2016 to Sep 2017v12
  13. 2 versions Re-verified since Aug 6, 2015, no change to tracked fieldsv10-v11
  14. Primary and study completion dates: Sep 2015 to Sep 2016v9
  15. Enrollment target: 30 to 50v8
  16. Eligibility criteria shortened, about 15 words
    • Secondary endpoints: details revised at 1 of 3 entries
    v7
  17. Primary and study completion dates: Sep 2014 to Sep 2015v6
  18. 2 versions Re-verified since Apr 8, 2013, no change to tracked fieldsv4-v5
  19. Eligibility criteria expanded, about 24 wordsv3
  20. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01697930
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Solid Malignancy, Lymphoma
Related terms Lymphoma
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov