Head and Neck NeoplasmsTRIGORANCT03345719
The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients
An observational study of Head and Neck Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial 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 within complex 3D anatomy has motivated the development of image-guidance systems that account for tissue deformation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- 3D Cone-Beam Imaging
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2012to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery to the head and neck and deemed eligible for this study by the investigators.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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 #.
- Conditions
- Head and Neck Neoplasms
- Being tested
- 3D Cone-Beam Imaging
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Cone-Beam ImagingDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 3D cone-beam imaging
Evaluate the performance of 3D cone-beam imaging in the operating room
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start4 Oct 2012
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345719
- Sponsor's protocol ID
- 12-5315
- Acronym
- TRIGORA
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2017
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients
- ClinicalTrials.gov ID
- NCT03345719
- Acronym / sponsor ID
- TRIGORA / 12-5315
- Conditions
- Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 #.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery to the head and neck and deemed eligible for this study by the investigators.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Cone-Beam Imaging | Diagnostic test | – |
Primary outcome
Evaluation of 3D cone-beam imaging
Time frame: intraoperative
Evaluate the performance of 3D cone-beam imaging in the operating room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of 3D cone-beam imaging (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.