Optical Imaging of Head and Neck Cancer

NCT01456143 | Terminated Results

• 1 other identifier: GCO 09-2057
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma; Neoplasia; Head and Neck Cancer

Keywords

Squamous Cell Carcinoma; Neoplasia; Optical imaging; Head and Neck Cancer; Oropharynx; Larynx; Oral Cavity

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

HRME with proflavine

EXPERIMENTAL

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); Other: Proflavine hemisulfate

Interventions

High Resolution Microendoscopy (HRME) DEVICE

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.

Also known as: HRME

HRME with proflavine

Proflavine hemisulfate OTHER

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

Also known as: Proflavine

HRME with proflavine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx
• Must be receiving surgical treatment for their cancer

You may not qualify if:

• Presence of medical or psychiatric condition affecting the ability to give informed consent
• Known allergy to Proflavin
• Pregnant or nursing Females

Sponsors & Collaborators

• Sharmila Anandasabapathy, MD: lead
• William Marsh Rice University: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Neoplasms; Head and Neck Neoplasms; Laryngeal Diseases

Interventions

Proflavine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms by Site; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Brett Miles
• Organization: Mt Sinai

Brett.Miles@mountsinai.org

Study Officials

• Andrew Sikora, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Sharmila Anandasabapathy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: October 20, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 1, 2018
• Results First Posted: June 14, 2016

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)