Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance
Primary Purpose
Oropharyngeal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative CT imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Oropharyngeal Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients (>18 years) seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract.
Exclusion Criteria:
- Patients who are unable to tolerate general anesthesia.
- Patients who are felt to be a "difficult airway" for induction of general endotracheal anesthesia.
- Patients with excessive dental restorations and amalgam.
Sites / Locations
- Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative CT imaging
Arm Description
Outcomes
Primary Outcome Measures
Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT02405000
First Posted
March 27, 2015
Last Updated
April 21, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02405000
Brief Title
Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance
Official Title
Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
October 24, 2017 (Actual)
Study Completion Date
October 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this research is to perform a pilot study on patients undergoing laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer) in which intraoperative CT imaging will be performed both prior to (but after induction of general endotracheal anesthesia) and during placement of the laryngoscope in order to better understand anatomic changes that occur during instrumentation of the oral cavity and oropharynx. The goals of the study are:
Develop a suite of de-identified images and surface renderings that qualitatively show how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic evaluation.
Create deformation models of the upper aerodigestive tract.
This data to be used for future retractor development as well as for virtual image guided surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative CT imaging
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Intraoperative CT imaging
Intervention Description
Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure
Primary Outcome Measure Information:
Title
Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy
Time Frame
Collected at the time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (>18 years) seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract.
Exclusion Criteria:
Patients who are unable to tolerate general anesthesia.
Patients who are felt to be a "difficult airway" for induction of general endotracheal anesthesia.
Patients with excessive dental restorations and amalgam.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Paydarfar, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance
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