Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

Condition Intervention
Squamous Cell Carcinoma
Neoplasia
Head and Neck Cancer
Device: High Resolution Microendoscopy (HRME)
Other: Proflavine hemisulfate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

Resource links provided by NLM:


Further study details as provided by Anandasabapathy, Sharmila, M.D.:

Primary Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: December 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456143

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10017
Sponsors and Collaborators
Sharmila Anandasabapathy, MD
William Marsh Rice University
Investigators
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
  More Information

Responsible Party: Sharmila Anandasabapathy, MD, Principle Investigator, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01456143     History of Changes
Other Study ID Numbers: GCO 09-2057 
Study First Received: October 14, 2011
Results First Received: February 29, 2016
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Anandasabapathy, Sharmila, M.D.:
Squamous Cell Carcinoma
Neoplasia
Optical imaging
Head and Neck Cancer
Oropharynx
Larynx
Oral Cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 09, 2016