Head and Neck Neoplasms Clinical Trial
— TRIGORAOfficial title:
The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients
NCT number | NCT03345719 |
Other study ID # | 12-5315 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 4, 2012 |
Est. completion date | March 31, 2019 |
Verified date | December 2019 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 within complex 3D anatomy has motivated the development of image-guidance
systems that account for tissue deformation and excision through the use of intraoperative
cone-beam CT (CBCT). A prototype mobile C-arm for intraoperative flat-panel CBCT has been
developed at UHN in collaboration with Siemens Healthcare to provide low-dose 3D images with
sub-mm spatial resolution and soft-tissue visibility. Extensive investigation in
pre-clinical/clinical H&N, otology, orthopaedic, lung, and spine surgery has demonstrated the
benefit of intraoperative CBCT for improved target ablation, localization accuracy, and
critical structure avoidance.
Prospective clinical trial in CBCT-guided H&N surgery will be conducted to evaluate the Zeego
robotic platform for CBCT. Patient accrual will span a wide range of surgical procedures in
otolaryngology, including cancer resection and anatomical reconstruction in the mandible,
maxilla, sinuses, skull base, and temporal bone. The effect of intraoperative imaging and
surgical guidance on logistical considerations of time, workflow, and compatibility with the
OR environment will be evaluated through the use of in-room audio/video recordings, human
factors engineering methods, and expert feedback questionnaires obtained from the surgeons,
nurses, and anesthetists involved in each case. This clinical investigation will help to
further define indications for CBCT-guided H&N surgery, and serve to enable the development
of surgical task-specific imaging protocols.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of 3D cone-beam imaging | Evaluate the performance of 3D cone-beam imaging in the operating room | intraoperative |
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