Clinical trial NCT01456143: Optical Imaging of Head and Neck Cancer
Official title: In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Squamous Cell Carcinoma
Neoplasia
Head and Neck Cancer
Keywords: Squamous Cell Carcinoma
Neoplasia
Optical imaging
Head and Neck Cancer
Oropharynx
Larynx
Oral Cavity
Lead sponsor: Anandasabapathy, Sharmila, M.D.
Sponsor class: INDIV
Collaborators: name: William Marsh Rice University
First posted: 2011-10-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy
timeFrame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
measure: Sensitivity
timeFrame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
measure: Specificity
timeFrame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
measure: Positive Predictive Value
timeFrame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
measure: Negative Predictive Value
timeFrame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
measure: Interrater Reliability
timeFrame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew Sikora, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Sharmila Anandasabapathy, MD
role: PRINCIPAL_INVESTIGATOR
References: