NCT01456143 · REGISTRY CONDITION SEARCH

Optical Imaging of Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2018-02-01

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Accuracy

→

outcome · POSTED

Sensitivity

→

outcome · POSTED

Specificity

→

outcome · POSTED

Positive Predictive Value

→

outcome · POSTED

Negative Predictive Value

→

outcome · POSTED

Interrater Reliability

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Device: High Resolution Microendoscopy (HRME)
Other: Proflavine hemisulfate
label
HRME with proflavine
type
EXPERIMENTAL

interventions

arm Group Labels
HRME with proflavine
description
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.
name
High Resolution Microendoscopy (HRME)
other Names
HRME
type
DEVICE
arm Group Labels
HRME with proflavine
description
0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
name
Proflavine hemisulfate
other Names
Proflavine
type
OTHER

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 33
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
measure
Accuracy
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
description
Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results
measure
Sensitivity
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
description
Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results
measure
Specificity
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
description
PPV = proportion of those with a positive test who have neoplasia compared to pathology results
measure
Positive Predictive Value
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
description
NPV = proportion of those with a negative test without neoplasia compared to pathology results
measure
Negative Predictive Value
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)
description
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.
measure
Interrater Reliability
time Frame
Immediately following image (day of enrollment or up to 2 weeks after enrollment)

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-c58035d6f19f61732775
requested nct id
NCT01456143
primary nct id
NCT01456143
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
payload sha256
1982f9670da185d6f9533a3d2e0c15773a503d752a10d3ae648481830b7a9221
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-c58035d6f19f61732775
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01456143
occurrences
context exact
NCT01456143
end
11
exact text
NCT01456143
start
0
offset unit
unicode_code_points
query cond
Laryngeal Cancer
query disease state id
ds-laryngeal-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
source file sha256
fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
source json pointer
/studies/125/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
e05fcdd35d38d2ed6a8de0ffbc160702c9d9e5da984c7cb1d069fa6ae9530551
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice