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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01456143
Other study ID # GCO 09-2057
Secondary ID
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
Health authority
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

Study Design


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)
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