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NCT01295931 · ClinicalTrials.gov registry record · Phase 1
Nuclear and Near-Infrared (NIR) Imaging in Melanoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01295931: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01295931 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01295931, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Objectives: 1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral) 2. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.
Primary Outcome
Procedure feasible if 18 out of 24 evaluable patients have 80% or more nodes identified by ICG among all resected nodes. Descriptive analyses performed to report the mean percentage and its 95% confidence interval of the nodes identified by ICG among the total resected nodes of all evaluable subjects. Outcome will be tabulated by age, different tumor stage, nodal status, and body mass index.
Interventions
- DRUG Indocyanine Green (IC-Green)
- PROCEDURE Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01295931 record still lists
NCT01295931 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Indocyanine Green (IC-Green) is the first listed.
NCT01295931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01295931 about?
NCT01295931 is a clinical study titled "Nuclear and Near-Infrared (NIR) Imaging in Melanoma". Objectives: 1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or in...
What is the current status of trial NCT01295931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-02. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01295931?
The interventions under investigation include: Indocyanine Green (IC-Green) (DRUG), Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT01295931?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01295931's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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