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NCT04719156 · ClinicalTrials.gov registry record · Phase 2
Fluorescent Intra-operative Tumor Margin Examination
A Phase 2 study of Sarcoma, sponsored by Kurt Weiss.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT04719156: Recruiting Phase 2 study of Sarcoma, sponsored by Kurt Weiss.
NCT04719156 is a Phase 2 study of Sarcoma that is actively recruiting participants, run by Kurt Weiss. The registered enrollment target is 110 participants, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04719156, a Phase 2 study of Sarcoma, is actively recruiting participants, sponsored by Kurt Weiss.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.
Primary Outcome
The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.
Conditions Studied
Interventions
- DRUG Indocyanine green solution administered at 2.0mg/kg.
- DEVICE Stryker SPY-PHI Imaging Device
Study Locations (1)
Pennsylvania
- UPMC-Shadyside Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04719156 shows while recruiting
NCT04719156 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Indocyanine green solution administered at 2.0mg/kg. is the first listed.
NCT04719156 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04719156 about?
NCT04719156 is a clinical study titled "Fluorescent Intra-operative Tumor Margin Examination". Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In pr...
What is the current status of trial NCT04719156?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2021-03-02. Estimated completion is 2026-12-31.
What conditions does trial NCT04719156 study?
This clinical trial studies the following conditions: Sarcoma.
What interventions are being tested in trial NCT04719156?
The interventions under investigation include: Indocyanine green solution administered at 2.0mg/kg. (DRUG), Stryker SPY-PHI Imaging Device (DEVICE).
Who is sponsoring clinical trial NCT04719156?
This trial is sponsored by Kurt Weiss, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04719156 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04719156's enrollment target sits among peer trials
110 40th of 122 higher than 83 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma 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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