Optical Imaging of Head and Neck Cancer
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| First Received Date ICMJE | October 14, 2011 | ||||||||
| Last Updated Date | August 10, 2012 | ||||||||
| Start Date ICMJE | December 2011 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Accuracy and Interrate Reliability of HRME Image Interpretation [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ] participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment. |
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| Original Primary Outcome Measures ICMJE |
Accuracy and Interrate Reliability of HRME Image Interpretation [ Time Frame: Immediatedly following image (day of enrollment or up to 2 weeks after enrollment) ] [ Designated as safety issue: No ] participants are imaged during their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment. |
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| Change History | Complete list of historical versions of study NCT01456143 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Image Correlation with standard of care histopathology [ Time Frame: Following surgical resection - (day of enrollment or up to 2 weeks after enrollment.) ] [ Designated as safety issue: No ] participants are imaged after their surgery. surgery is either on the day of enrollment or can be scheduled up to 2 weeks after enrollment. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Optical Imaging of Head and Neck Cancer | ||||||||
| Official Title ICMJE | In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia | ||||||||
| Brief Summary | This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: Squamous Cell Carcinoma
Patients with Head and Neck Squamous Cell Carcinoma undergoing surgical resection
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 77 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01456143 | ||||||||
| Other Study ID Numbers ICMJE | 09-2057 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Sharmila Anandasabapathy, Mount Sinai School of Medicine | ||||||||
| Study Sponsor ICMJE | Sharmila Anandasabapathy | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Mount Sinai School of Medicine | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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