Status:

COMPLETED

The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients

Lead Sponsor:

University Health Network, Toronto

Conditions:

Head and Neck Neoplasms

Eligibility:

All Genders

18+ years

Brief Summary

Head and neck cancer surgery presents the challenge of tumour resection in close proximity to critical structures such as the carotid arteries and optic nerves. The need for precise localization withi...

Detailed Description

For each patient enrolled in this study, the following administrative information will be compiled and maintained by the Principal Investigator at Princess Margaret Hospital: Consent Form: The signed...

Eligibility Criteria

Inclusion

  • The study will include patients with tumors or other masses in the following sites, nasal cavity, sinuses, nasopharynx, parapharyngeal space, deep parotid salivary glands, oral cavity, oropharynx, and skull base. Cases considered in this study will include lesions in one or several of these sites.
  • The patients are intended to undergo surgical treatment for their disease. The patients should have a complete and detailed medical record. Subjects must be at least 18 years of age. Subjects must sign and be given a copy of the written Informed Consent Form.

Exclusion

  • Patients with unresectable lesions, where surgery is not the treatment of choice.
  • Patients who are not able to consent by themselves or grasp the implication of the study.
  • Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation.
  • Subjects may be excluded from this study at the discretion of a Clinical Co-Investigator, if they are enrolled in other studies that will result in combined radiation exposure exceeding standard of care.
  • Subjects who are pregnant, lactating, or planning to become pregnant during the period of the evaluation.

Key Trial Info

Start Date :

October 4 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 31 2019

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT03345719

Start Date

October 4 2012

End Date

March 31 2019

Last Update

December 4 2019

Active Locations (1)

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1

University Health Network

Toronto, Ontario, Canada, M5G2M9