Squamous Cell CarcinomaNCT01456143
Optical Imaging of Head and Neck Cancer
A study testing High Resolution Microendoscopy (HRME) and Proflavine hemisulfate in people with Squamous Cell Carcinoma and Neoplasia, run by Sharmila Anandasabapathy, MD at 1 site in United States.
Trial summary
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer
- What is being tested?
- High Resolution Microendoscopy (HRME) and Proflavine hemisulfate
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx
- Must be receiving surgical treatment for their cancer
Who cannot join
- Presence of medical or psychiatric condition affecting the ability to give informed consent
- Known allergy to Proflavin
- Pregnant or nursing Females
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10017
About this study
Official title: In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.
Read the 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.
- Conditions
- Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer
- Being tested
- High Resolution Microendoscopy (HRME), Proflavine hemisulfate
- Keywords
- Squamous Cell Carcinoma, Neoplasia, Optical imaging, Head and Neck Cancer, Oropharynx, Larynx, Oral Cavity
- Medical subject headings
- Carcinoma, Squamous Cell, Neoplasms, Head and Neck Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Microendoscopy (HRME)Device
Also called 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.
Proflavine hemisulfateOther
Also called Proflavine
0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
| Study group | Role | What they receive |
|---|---|---|
| HRME with proflavine | Experimental | 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. Receives: Device: High Resolution Microendoscopy (HRME); Other: Proflavine hemisulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Immediately following image (day of enrollment or up to 2 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: PI left, study to be re-open with new PI, no planned data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharmila Anandasabapathy, MD
- Collaborators
- William Marsh Rice University
- Responsible party
- Sponsor-investigator, Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
- Investigators
- Andrew Sikora, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiSharmila Anandasabapathy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456143
- Sponsor's protocol ID
- GCO 09-2057
- Status last verified
- Jan 2018
- First submitted
- 14 Oct 2011
- Last updated
- 1 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
- ClinicalTrials.gov ID
- NCT01456143
- Acronym / sponsor ID
- GCO 09-2057
- Conditions
- Squamous Cell Carcinoma, Neoplasia, Head and Neck Cancer
- Keywords
- Squamous Cell Carcinoma, Neoplasia, Optical imaging, Head and Neck Cancer, Oropharynx, Larynx, Oral Cavity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left, study to be re-open with new PI, no planned data analysis
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sharmila Anandasabapathy, MD
- Collaborators
- William Marsh Rice University
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Posted 14 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRME with proflavine | Experimental | Device: High Resolution Microendoscopy (HRME), Other: Proflavine hemisulfateHigh 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx
- Must be receiving surgical treatment for their cancer
Key exclusion criteria (3 listed)
- Presence of medical or psychiatric condition affecting the ability to give informed consent
- Known allergy to Proflavin
- Pregnant or nursing Females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Resolution Microendoscopy (HRME)Also: HRMEHigh 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. | Device | HRME with proflavine |
| Proflavine hemisulfateAlso: Proflavine0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa | Other | HRME with proflavine |
Primary outcome
Accuracy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sikora, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Sharmila Anandasabapathy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Resolution Microendoscopy (HRME) and Proflavine hemisulfate in people with Squamous Cell Carcinoma and Neoplasia, run by Sharmila Anandasabapathy, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.