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Optical Imaging of Head and Neck Cancer

This study has been terminated.
(PI left, study to be re-open with new PI, no planned data analysis)
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01456143
First received: October 14, 2011
Last updated: May 6, 2016
Last verified: May 2016

October 14, 2011
May 6, 2016
December 2011
July 2014   (final data collection date for primary outcome measure)
  • Accuracy [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
  • Sensitivity [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
  • Specificity [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
  • Positive Predictive Value [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    PPV = proportion of those with a positive test who have neoplasia compared to pathology results
  • Negative Predictive Value [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    NPV = proportion of those with a negative test without neoplasia compared to pathology results
  • Interrater Reliability [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
    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.
Accuracy and Interrate Reliability of HRME Image Interpretation [ Time Frame: Immediatedly following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ]
participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.
Complete list of historical versions of study NCT01456143 on ClinicalTrials.gov Archive Site
Not Provided
Image Correlation with standard of care histopathology [ Time Frame: Following surgical resection - (day of enrollment or up to 2 weeks after enrollment.) ] [ Designated as safety issue: No ]
participants are imaged after their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment.
Not Provided
Not Provided
 
Optical Imaging of Head and Neck Cancer
In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Carcinoma
  • Neoplasia
  • Head and Neck Cancer
  • 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 Name: HRME
  • Other: Proflavine hemisulfate
    0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
    Other Name: Proflavine
Experimental: HRME with proflavine
High Resolution Microendoscopy (HRME) 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. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
Interventions:
  • Device: High Resolution Microendoscopy (HRME)
  • Other: Proflavine hemisulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01456143
GCO 09-2057
No
Yes
Not Provided
Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
Sharmila Anandasabapathy, MD
William Marsh Rice University
Principal Investigator: Andrew Sikora, MD, PhD Icahn School of Medicine at Mount Sinai
Principal Investigator: Sharmila Anandasabapathy, MD Icahn School of Medicine at Mount Sinai
Anandasabapathy, Sharmila, M.D.
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP