The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients (TRIGORA)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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 #.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Ontario
-
Toronto, Ontario, Canada, M5G2M9
- University Health Network
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluation of 3D cone-beam imaging
Tijdsspanne: intraoperative
|
Evaluate the performance of 3D cone-beam imaging in the operating room
|
intraoperative
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12-5315
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .