Clinical Trials Directory

Trials / Terminated

TerminatedNCT03297957

Fluorescence Imaging in Head and Neck Cancer

Evaluation of Fluorescence Imaging in Head and Neck Cancer

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEHands-free goggle system-Manufactured at Washington University

Timeline

Start date
2017-09-14
Primary completion
2019-04-15
Completion
2019-04-15
First posted
2017-09-29
Last updated
2020-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03297957. Inclusion in this directory is not an endorsement.