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NCT03297957 · ClinicalTrials.gov registry record · NA
Fluorescence Imaging in Head and Neck Cancer
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03297957 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 28 participants.
The verdict
NCT03297957, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure. Regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. These glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. Therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid function in this patient population as well.
Interventions
- DEVICE Hands-free goggle system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2019-04-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03297957
The ClinicalTrials.gov registry entry for NCT03297957 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hands-free goggle system is the first listed.
NCT03297957 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03297957 about?
NCT03297957 is a clinical study titled "Fluorescence Imaging in Head and Neck Cancer". Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied spec...
What is the current status of trial NCT03297957?
This trial is currently terminated. It is a NA study. The enrollment target is 28 participants. The study started on 2017-09-14. Estimated completion is 2019-04-15.
What interventions are being tested in trial NCT03297957?
The interventions under investigation include: Hands-free goggle system (DEVICE).
Who is sponsoring clinical trial NCT03297957?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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