Optical Imaging of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01456143
• Other study ID #: GCO 09-2057
• Status: Terminated
• Phase: N/A
• First received: October 14, 2011
• Last updated: January 8, 2018
• Start date: December 2011
• Est. completion date: July 2014

Study information

• Verified date: January 2018
• Source: Anandasabapathy, Sharmila, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

Description:

The purpose of this study is to determine if optical imaging modalities used at the time of surgical resection for head and neck squamous cell carcinoma can help delineate normal from cancerous mucosa. The High resolution microendoscope, developed by our collaborators at Rice university, can allow for real time visualization of tissue nuclei. The overall aim of this study is to determine if this device can be used to enhance the accuracy of intraoperative margin detection during tumor resection for head and neck cancer.

At the time of tumor resection for head and neck squamous cell carcinoma, a wide field imaging device will be used to identify suspicious areas. The High resolution device will then image representative areas from the tumor, the tumor margin, and normal mucosa. A topical dye, proflavin, will be placed on the tissue to enhance the visualization of nuclei prior to imaging with the HRME device. Following imaging, biopsies of the imaged areas will be taken and submitted for pathology diagnosis. The images of the biopsies will then be compared and the device will be evaluated for accuracy of margin detection at the time of tumor resection.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx

• Must be receiving surgical treatment for their cancer

Exclusion Criteria:

• Presence of medical or psychiatric condition affecting the ability to give informed consent

• Known allergy to Proflavin

• Pregnant or nursing Females

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplasia
• Neoplasms
• Squamous Cell Carcinoma

Intervention

Device:
• High Resolution Microendoscopy (HRME)
High Resolution Microendoscopy imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer.

Other:
• Proflavine hemisulfate
0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sharmila Anandasabapathy, MD	William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results	Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Primary	Sensitivity	Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results	Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Primary	Specificity	Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results	Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Primary	Positive Predictive Value	PPV = proportion of those with a positive test who have neoplasia compared to pathology results	Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Primary	Negative Predictive Value	NPV = proportion of those with a negative test without neoplasia compared to pathology results	Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Primary	Interrater Reliability	Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.	Immediately following image (day of enrollment or up to 2 weeks after enrollment)