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NCT05322135 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT05322135: Clinical Trial Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT05322135 is a Early Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05322135, a Early Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
We propose a focused, prospective pilot clinical imaging trial to evaluate 11C-Gln PET/CT followed by 18F-FSPG PET/CT in 20 HNSCC patients. Imaging metrics that are common to PET (e.g. SUVmax, peak or mean) will be determined. This study will also allow the acquisition of additional safety and biodistribution data, as, to date, only a limited number of patients have been evaluated with 11C-Gln as a direct PET imaging biomarker of Gln uptake. To date, no adverse side effects have been observed. We do not anticipate any toxicity since this tracer is a naturally-occurring essential amino acid in high abundance and is administered at sub-pharmacologic doses. A long-term goal of these preliminary studies is to validate the utility of Gln PET imaging metrics for HNSCC and to expand this imaging technique to additional patients in prospective cohorts of patients with HNSCC.
Interventions
- DRUG 18F-FSPG
- DRUG 11C-Glutamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2025-03-07 |
| Phase | Early Phase 1 |
Why NCT05322135 stopped before completion
NCT05322135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which 18F-FSPG is the first listed.
NCT05322135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05322135 about?
NCT05322135 is a clinical study titled "A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma". We propose a focused, prospective pilot clinical imaging trial to evaluate 11C-Gln PET/CT followed by 18F-FSPG PET/CT in 20 HNSCC patients. Imaging metrics that are common to PET (e.g. SUVmax, peak or mean) will be determined. This study will also allow the acquisition of additional safety and biod...
What is the current status of trial NCT05322135?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2022-09-14. Estimated completion is 2025-03-07.
What interventions are being tested in trial NCT05322135?
The interventions under investigation include: 18F-FSPG (DRUG), 11C-Glutamine (DRUG).
Who is sponsoring clinical trial NCT05322135?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05322135's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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