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NCT05101798 · ClinicalTrials.gov registry record · Phase 2
The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT05101798: Clinical Trial Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05101798 is a Phase 2 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101798, a Phase 2 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperatively. Using specific wavelengths of light as well as specialized magnified lenses the surgeons use this technique to assist in tumor resection.
Primary Outcome
The feasibility of using oral Gleolan® as an adjunct diagnostic imaging tool for malignant tumor tissue fluorescence will be primarily assessed by computing sensitivity of intraoperative Gleolan® induced PPIX tissue fluorescence. PPIX tissue fluorescence will be defined categorically as "no" (score 0), "low" (score 1), "medium" (score 2), and "high" (score 3) by operative surgeon, and images will be recorded. For purposes of computing measures of diagnostic performance a score of 0 will be cons
Interventions
- DRUG 5-Aminolevulinic acid Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2022-12-25 |
| Phase | Phase 2 |
Why NCT05101798 stopped before completion
NCT05101798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Aminolevulinic acid Hydrochloride is the first listed.
NCT05101798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05101798 about?
NCT05101798 is a clinical study titled "The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial". This study allows head and neck cancer surgeons to specifically visualize cancerous cells apart from normal healthy tissue. 5-aminolevulinic acid (5-ALA) is a safe and effective FDA-approved agent successfully used by neurosurgeons for FGS of different brain tumors is given to the patients preoperat...
What is the current status of trial NCT05101798?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-09-14. Estimated completion is 2022-12-25.
What interventions are being tested in trial NCT05101798?
The interventions under investigation include: 5-Aminolevulinic acid Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05101798?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05101798's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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