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Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation Study (EndoscopicHN)

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ClinicalTrials.gov Identifier: NCT03380208
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date November 14, 2017
First Posted Date December 21, 2017
Last Update Posted Date April 17, 2019
Actual Study Start Date December 1, 2017
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2017)
CT image comparison of lesions visible in the oral cavity with pathological findings of the resected specimen. [ Time Frame: intraop ]
Relative spatial overlap of mucosal lesions in the oral cavity as detected by endoscopic imaging and gross tumor as detected by CT imaging, with confirmation of lesion pathology and location determined by whole mount pathology of the resected samples. The endoscopic imaging is co-registered to the CT image set using tracking devices embedded inside the endoscopes.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03380208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation Study
Official Title Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation
Brief Summary

The purpose of this clinical research is to compare new methods of identifying the locations of tumours to standard CT imaging. Analysis of the tissue removed during surgery (pathology) will be used to determine which method is more accurate. Accurately identifying the locations of tumours is especially important for radiation therapy, where the radiation needs to cover the entire tumour while minimizing the amount normal tissue that is exposed to radiation. The new method uses optical imaging (endoscopy) that can be mapped to the CT imaging using device tracking technologies. CT imaging is used to create the radiation treatment plans and so tumour locations are normally provided by CT images. The advantage of the new technology that is being tested is that it may be able to locate regions of a tumour that are at the surface of the tissue. These tumours are difficult to see using CT imaging but easy to see using optical imaging. Currently, there is no accurate way of mapping the optical imaging to the CT images used in radiation therapy.

This study will enable the investigators to test the new optical imaging by comparing the tumour that the investigators identify using CT imaging alone against using CT imaging plus the optical imaging technology. The results from this imaging will be compared to pathology findings.

Detailed Description

a CT image that includes a contrast agent that helps to identify the location of the tumour. Small markers will be placed on the participants head prior to the scan so that the investigators can align this CT image with the tracking technology used during the surgery.

The participant will be moved to the surgical table, where the surgery will proceed as it would for standard of care procedures. The tracking technology and optical imaging will be used to identify where the tumour is located at the tissue surface

  • Tumour tissue and extra tissue surrounding the tumour will be removed, as would occur normally in surgery. Some markers may be placed on the tissue where it is cut. These will be helpful in matching the tissue that is removed with its location in the images.
  • A second CT image will be taken immediately following the tissue removal. This will be made using an imaging device called a cone beam CT.
  • In collaboration with the pathology department, whole mount tissue samples will be assessed to determine the location of tumour tissue. Using the markings on the tissue and images taken of the tissue sample after it has been removed, the location of the tumour in the tissue sample will be compared to the location of the tumour in the CT image and the location of the surface tumour determined by the optical imaging technology.
  • The CT images may be analyzed by radiation oncologists, surgeons and physicists.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with head and neck cancer, specifically of the oral cavity
Condition Head and Neck Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 15, 2017)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients will be eligible for inclusion in this study if they meet all of the following criteria:

Age ≥ 18 years Histologic diagnosis of oral squamous cell carcinoma Primary cancer of the H&N Intention to treat using surgery. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Prior complete or partial radiation therapy to H&N Prior complete or partial surgery of the tumour Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning Psychiatric or addictive disorders that preclude informed consent or adherence to protocol
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Robert Weersink, Dr. 416-581-7797 Robert.Weersink@rmp.uhn.ca
Contact: Jonathan Irish, Dr. jonathan.irish@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03380208
Other Study ID Numbers 17-5386
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan Irish, Dr. University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date April 2019