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PI left, study to be re-open with new PI, no planned data analysis
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| Name | Class |
|---|---|
| William Marsh Rice University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10017 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HRME With Proflavine Hemisulfate | High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy | Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results | Posted | Mean | 95% Confidence Interval | Percent of images with correct diagnosis | Immediately following image (day of enrollment or up to 2 weeks after enrollment) |
|
(day of enrollment or up to 2 weeks after enrollment)]
Serious and other adverse events were monitored and assessed, but none were observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HRME With Proflavine Hemisulfate | High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Miles | Mt Sinai | Brett.Miles@mountsinai.org |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D011370 | Proflavine |
| ID | Term |
|---|---|
| D000609 | Aminoacridines |
| D000166 | Acridines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Proflavine hemisulfate | Other | 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa |
|
|
| Immediately following image (day of enrollment or up to 2 weeks after enrollment) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Sensitivity | Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results | Posted | Mean | 95% Confidence Interval | Percent of images with correct diagnosis | 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 | Posted | Mean | 95% Confidence Interval | Percent of images with correct diagnosis | 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 | Posted | Mean | 95% Confidence Interval | Percent of images with correct diagnosis | 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 | Posted | Mean | 95% Confidence Interval | Percent of images with correct diagnosis | 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. | Posted | Number | 95% Confidence Interval | proportion of agreement among 11 experts | Immediately following image (day of enrollment or up to 2 weeks after enrollment) |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
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| D009371 | Neoplasms by Site |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006571 | Heterocyclic Compounds |