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NCT07038278 · ClinicalTrials.gov registry record · Early Phase 1
5-AminoLevulinic Acid Aided Resection Margins in Sarcoma
A Early Phase 1 study, sponsored by University of Colorado, Denver.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT07038278 is a Early Phase 1 study that has not yet begun recruiting, run by University of Colorado, Denver. The registered enrollment target is 20 participants.
The verdict
NCT07038278, a Early Phase 1 study, has not yet begun recruiting, sponsored by University of Colorado, Denver.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.
Interventions
- DRUG 5-ALA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2028-11-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07038278
The ClinicalTrials.gov registry entry for NCT07038278 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5-ALA is the first listed.
NCT07038278 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07038278 about?
NCT07038278 is a clinical study titled "5-AminoLevulinic Acid Aided Resection Margins in Sarcoma". The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up w...
What is the current status of trial NCT07038278?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-04-01. Estimated completion is 2028-11-01.
What interventions are being tested in trial NCT07038278?
The interventions under investigation include: 5-ALA (DRUG).
Who is sponsoring clinical trial NCT07038278?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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