An interventional study of High Resolution Microendoscopy (HRME) and Proflavine hemisulfate in Squamous Cell Carcinoma, Neoplasia and Head and Neck Cancer, sponsored by Sharmila Anandasabapathy, MD. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Sharmila Anandasabapathy, MD · Not applicable, Interventional, and Treatment
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.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's enrollment of 33 is below the median of 44 across 1,414 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →This is the only study on the registry with Sharmila Anandasabapathy, MD as lead sponsor.
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Exclusion Criteria:
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
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
0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
Also known as: Proflavine
Accuracy
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
| Milestone | HRME With Proflavine |
|---|---|
| Started | 33 |
| Completed | 33 |
| Not completed | 0 |
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
| Percent of images with correct diagnosis | HRME With Proflavine |
|---|---|
| Accuracy | 95.1 (94 to 96) |
Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
| Percent of images with correct diagnosis | HRME With Proflavine |
|---|---|
| Sensitivity | 96 (94 to 99) |
Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
| Percent of images with correct diagnosis | HRME With Proflavine |
|---|---|
| Specificity | 95 (90 to 99) |
PPV = proportion of those with a positive test who have neoplasia compared to pathology results
| Percent of images with correct diagnosis | HRME With Proflavine |
|---|---|
| Positive Predictive Value | 91 (85 to 98) |
NPV = proportion of those with a negative test without neoplasia compared to pathology results
| Percent of images with correct diagnosis | HRME With Proflavine |
|---|---|
| Negative Predictive Value | 98 (97 to 99) |
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.
| proportion of agreement among 11 experts | HRME With Proflavine |
|---|---|
| Interrater Reliability | .81 (.78 to .84) |
Collected over (day of enrollment or up to 2 weeks after enrollment)]. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HRME With Proflavine Hemisulfate | — | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | HRME With Proflavine Hemisulfate |
|---|---|
| Mean | 59.09 ± 12.47 |
| Sex: Female, Male(Participants) | HRME With Proflavine Hemisulfate |
|---|---|
| Female | 14 |
| Male | 19 |
| Region of Enrollment(participants) | HRME With Proflavine Hemisulfate |
|---|---|
| United States | 33 |
Plan to share: Yes
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