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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: Clinical Trial Early Phase 1 study, sponsored by University of Colorado, Denver.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients will receive 5-ALA administered in the preoperative area. Surgical resection of the soft tissue sarcoma will be done as per standard of care. A fluorescent headset will be turned on at defined time points below and tumor fluorescence will be noted (yes or no): 1. prior to skin incision 2. once dissection has reached fascial layer 3. when 50% of the tumor superficial-to-deep has been dissected 4. following complete resection of the tumor.
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 |
What is known before NCT07038278 opens enrollment
NCT07038278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-ALA is the first listed.
NCT07038278 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07038278's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 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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