Fluorescence Imaging in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Evaluation of Fluorescence Imaging in Head and Neck Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03297957
• Other study ID #: 201708068
• Status: Terminated
• Phase: N/A
• Start date: September 14, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 years or older will be considered eligible.

• Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection.

• Candidates for sentinel lymph node biopsy or central neck surgery

• Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.

• Not pregnant or breast feeding.

• Able to understand and willing to sign an IRB-approved written informed consent document.

• Able to understand written or spoken English.

Exclusion Criteria:

• History of allergy to iodide drugs or shellfish (iodine allergy)

• Pregnant or breast feeding

• Do not fit age criteria

• Prisoners

• Unable to provide written consent

• Contraindications for surgery

*Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Receiving any other investigational agents

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Hands-free goggle system
-Manufactured at Washington University

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure	-Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully	Up to 1 week after surgery
Primary	Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure	-Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device	Up to 1 week after surgery
Primary	Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure	-Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy	Up to 1 week after surgery
Primary	Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure	-Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device	Up to 1 week after surgery
Primary	Ability of the hands-free goggle system to identify parathryoid glands during central neck surgeries		Up to 1 week after surgery
Secondary	Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device		Up to 1 week after surgery

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine