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Optical Imaging of Head and Neck Cancer

This study has been terminated.
(PI left, study to be re-open with new PI, no planned data analysis)
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01456143
First received: October 14, 2011
Last updated: May 6, 2016
Last verified: May 2016
Results First Received: February 29, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Squamous Cell Carcinoma
Neoplasia
Head and Neck Cancer
Interventions: Device: High Resolution Microendoscopy (HRME)
Other: Proflavine hemisulfate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HRME With Proflavine 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.

Participant Flow:   Overall Study
    HRME With Proflavine  
STARTED     33  
COMPLETED     33  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
HRME With Proflavine Hemisulfate High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent

Baseline Measures
    HRME With Proflavine Hemisulfate  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Mean (Standard Deviation)
  59.09  (12.47)  
Gender  
[units: participants]
 
Female     14  
Male     19  
Region of Enrollment  
[units: participants]
 
United States     33  



  Outcome Measures
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1.  Primary:   Accuracy   [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ]

2.  Primary:   Sensitivity   [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ]

3.  Primary:   Specificity   [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ]

4.  Primary:   Positive Predictive Value   [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ]

5.  Primary:   Negative Predictive Value   [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ]

6.  Primary:   Interrater Reliability   [ Time Frame: Immediately following image (day of enrollment or up to 2 weeks after enrollment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brett Miles
Organization: Mt Sinai
e-mail: Brett.Miles@mountsinai.org



Responsible Party: Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01456143     History of Changes
Other Study ID Numbers: GCO 09-2057
Study First Received: October 14, 2011
Results First Received: February 29, 2016
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration