Trial Outcomes & Findings for Optical Imaging of Head and Neck Cancer (NCT NCT01456143)
NCT ID: NCT01456143
Last Updated: 2018-02-01
Results Overview
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
TERMINATED
NA
33 participants
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
2018-02-01
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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33
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Overall Study
COMPLETED
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33
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optical Imaging of Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
HRME With Proflavine Hemisulfate
n=33 Participants
High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
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|---|---|
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Age, Continuous
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59.09 years
STANDARD_DEVIATION 12.47 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
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Region of Enrollment
United States
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33 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Immediately following image (day of enrollment or up to 2 weeks after enrollment)Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
Outcome measures
| Measure |
HRME With Proflavine
n=33 Participants
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.
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|---|---|
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Accuracy
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95.1 Percent of images with correct diagnosis
Interval 94.0 to 96.0
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PRIMARY outcome
Timeframe: Immediately following image (day of enrollment or up to 2 weeks after enrollment)Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
Outcome measures
| Measure |
HRME With Proflavine
n=33 Participants
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.
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|---|---|
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Sensitivity
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96 Percent of images with correct diagnosis
Interval 94.0 to 99.0
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PRIMARY outcome
Timeframe: Immediately following image (day of enrollment or up to 2 weeks after enrollment)Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
Outcome measures
| Measure |
HRME With Proflavine
n=33 Participants
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.
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|---|---|
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Specificity
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95 Percent of images with correct diagnosis
Interval 90.0 to 99.0
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PRIMARY outcome
Timeframe: Immediately following image (day of enrollment or up to 2 weeks after enrollment)PPV = proportion of those with a positive test who have neoplasia compared to pathology results
Outcome measures
| Measure |
HRME With Proflavine
n=33 Participants
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.
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|---|---|
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Positive Predictive Value
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91 Percent of images with correct diagnosis
Interval 85.0 to 98.0
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PRIMARY outcome
Timeframe: Immediately following image (day of enrollment or up to 2 weeks after enrollment)NPV = proportion of those with a negative test without neoplasia compared to pathology results
Outcome measures
| Measure |
HRME With Proflavine
n=33 Participants
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.
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|---|---|
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Negative Predictive Value
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98 Percent of images with correct diagnosis
Interval 97.0 to 99.0
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PRIMARY outcome
Timeframe: Immediately following image (day of enrollment or up to 2 weeks after enrollment)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.
Outcome measures
| Measure |
HRME With Proflavine
n=33 Participants
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.
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|---|---|
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Interrater Reliability
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.81 proportion of agreement among 11 experts
Interval 0.78 to 0.84
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Adverse Events
HRME With Proflavine Hemisulfate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place