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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05322135
The ClinicalTrials.gov registry entry for NCT05322135 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 18F-FSPG is the first listed.
NCT05322135 reports 0 study locations.
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.
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