Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance

NCT02405000 | Completed DMC

• 1 other identifier: D14189
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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:

1. 1.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.
2. 2.Create deformation models of the upper aerodigestive tract.

Conditions

Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy

  Collected at the time of surgery

Study Arms (1)

Intraoperative CT imaging

EXPERIMENTAL

Other: Intraoperative CT imaging

Interventions

Intraoperative CT imaging OTHER

Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure

Intraoperative CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Joseph A Paydarfar, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: April 1, 2015
• Primary Completion: October 24, 2017
• Study Completion: October 24, 2017
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)