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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 : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease
Head and Neck Cancer

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
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Endoscopic Visualization and CT Imaging of Head and Neck Cancers With Pathological Validation
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with head and neck cancer, specifically of the oral cavity
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380208


Contacts
Contact: Robert Weersink, Dr. 416-581-7797 Robert.Weersink@rmp.uhn.ca
Contact: Jonathan Irish, Dr. jonathan.irish@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Robert Weersink, Dr.       robert.weersink@rmp.uhn.ca   
Principal Investigator: Robert Weersink, Dr         
Principal Investigator: Jonathan Irish, Dr.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Jonathan Irish, Dr. University Health Network, Toronto
  Study Documents (Full-Text)

Documents provided by University Health Network, Toronto:
Study Protocol  [PDF] July 5, 2017


Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03380208     History of Changes
Other Study ID Numbers: 17-5386
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms