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NCT06035068 · ClinicalTrials.gov registry record
SLN Mapping and ICG Dye for Vulvar Cancer
A clinical trial, sponsored by Tufts Medical Center.
- Not yet
- Registry status
- 10
- Enrollment target
NCT06035068: Clinical Trial study, sponsored by Tufts Medical Center.
NCT06035068 is a clinical trial that has not yet begun recruiting, run by Tufts Medical Center. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06035068 has not yet begun recruiting, sponsored by Tufts Medical Center.
- NOT YET RECRUITING
- Registry status
- 10 participants
- Enrollment target
Study Summary
Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.
Primary Outcome
* Report the detection rate of SLNs using ICG dye for sentinel lymph node mapping. * Report the detection rate of SLNs using blue dye for sentinel lymph node mapping. * Compare the two detection rates using a chi-squared test or Fisher's exact test, depending on the sample size.
Interventions
- DRUG Indocyanine green
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2026-01 |
What is known before NCT06035068 opens enrollment
NCT06035068 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Indocyanine green is the first listed.
NCT06035068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06035068 about?
NCT06035068 is a clinical study titled "SLN Mapping and ICG Dye for Vulvar Cancer". Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked abou...
What is the current status of trial NCT06035068?
This trial is currently not yet recruiting. The enrollment target is 10 participants. The study started on 2025-11-01. Estimated completion is 2026-01.
What interventions are being tested in trial NCT06035068?
The interventions under investigation include: Indocyanine green (DRUG).
Who is sponsoring clinical trial NCT06035068?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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