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NCT07650656 · ClinicalTrials.gov registry record · Phase 2
Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
A Phase 2 study, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT07650656: Recruiting Phase 2 study, sponsored by City of Hope Medical Center.
NCT07650656 is a Phase 2 study that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07650656, a Phase 2 study, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma. Surgical margins are one of the criteria used in assessing the effectiveness of a given surgical procedure. They are the edges or border of the tissue removed in cancer surgery. A negative margin means that the resected tumor is surrounded by normal tissue, which implies there is no disease left in the patient. By contrast, a positive margin means that sarcoma cells are visible at the edge of the tumor. Positive margins may be classified as planned when they are expected pre-operatively due to the preservation of a critical structure, or unexpected when the pathologist reports the presence of tumor at the margin despite the surgeon having intended to remove it in its entirety. Fluorescence-guided surgery is an established surgical method that involves the administration of fluorescent dye (in this case, indocyanine green) into the tumor, which can then be visualized with a special camera during surgery to help surgeons identify tumor versus healthy tissue. Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma.
Primary Outcome
The margin status of each tumor will be taken from the pathology report for each patient enrolled in the trial. This will be recorded at six months post- surgery and will be classified according to the R classification system. The UPM rate for each arm will be defined by calculating the percentage of patients in that arm with a UPM on histopathological assessment of the resection specimen. The percentage of patients with unexpected positive margins will be calculated for each group to give the u
Interventions
- DRUG Indocyanine Green
- OTHER Questionnaire Administration
- OTHER Electronic Health Record Review
- PROCEDURE Fluorescence Imaging
- PROCEDURE Fluorescence-Guided Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2027-05-15 |
| Est. Completion | 2028-05-11 |
| Phase | Phase 2 |
What NCT07650656 shows while recruiting
NCT07650656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Indocyanine Green is the first listed.
NCT07650656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07650656 about?
NCT07650656 is a clinical study titled "Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial". This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma. Surgical margins are one of the criteria used in assessing the effective...
What is the current status of trial NCT07650656?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2027-05-15. Estimated completion is 2028-05-11.
What interventions are being tested in trial NCT07650656?
The interventions under investigation include: Indocyanine Green (DRUG), Questionnaire Administration (OTHER), Electronic Health Record Review (OTHER), Fluorescence Imaging (PROCEDURE), Fluorescence-Guided Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT07650656?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07650656's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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