Optical Imaging of Head and Neck Cancer

In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456143

Enrollment

Registered

2011-10-20

Start date

2011-12-31

Completion date

2014-07-31

Last updated

2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer

Keywords

Squamous Cell Carcinoma, Neoplasia, Optical imaging, Head and Neck Cancer, Oropharynx, Larynx, Oral Cavity

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.

Interventions

DEVICEHigh Resolution Microendoscopy (HRME)

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.

OTHERProflavine hemisulfate

0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy	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
Sensitivity	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
Specificity	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
Positive Predictive Value	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
Negative Predictive Value	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
Interrater Reliability	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
HRME With Proflavine Hemisulfate High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent	33
Total	33

Baseline characteristics

Characteristic	HRME With Proflavine Hemisulfate
Age, Continuous	59.09 years STANDARD_DEVIATION 12.47
Region of Enrollment United States	33 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	19 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 33
serious Total, serious adverse events	0 / 33

Outcome results

Primary

Accuracy

Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results