Head and Neck Cancer Clinical Trial
Official title:
In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
Verified date | January 2018 |
Source | Anandasabapathy, Sharmila, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Sharmila Anandasabapathy, MD | William Marsh Rice University |
United States,
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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