Head and Neck Neoplasms Clinical Trial
Official title:
The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients
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.
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 consent form. (Note that the Consent Form is the only information
collected in this study that is not anonymous. All subsequent information is identified by an
arbitrary Code # that can not be directly or indirectly traced back to the individual
patient.) Clinical Summary: A brief summary provided by the Clinical Co-Investigator and/or
Surgical Fellow regarding the patient's illness and prescribed surgical treatment plan. The
Clinical Summary is anonymous with respect to patient identity and will be identified by an
arbitrary Code #. The Summary will include age, weight, height, sex, diagnosis, stage, habits
(viz., smoking and alcohol consumption), results of physical examination, and relevant
medical history (e.g., prior surgery). This will also include medical history related to
suitability for IV contrast (see the form included with the protocol).
Procedure Log: A summary log of the surgical procedure and imaging studies, when and where
they were carried out, and relevant notes regarding the surgical and imaging procedures
therein e.g., success or failure of the treatment plan or imaging system, etc. The Procedure
Log is also anonymous and identified by an arbitrary Code #.
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