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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.
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
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| Measure | Description | Time Frame |
|---|---|---|
| CT image comparison of lesions visible in the oral cavity with pathological findings of the resected specimen. | 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. | intraop |
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Inclusion 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:
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Patients with head and neck cancer, specifically of the oral cavity
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Irish, Dr. | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G2M9 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2017 | Dec 7, 2017 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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