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Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02279459
Collaborator
GE Healthcare (Industry)
23
Enrollment
1
Location
48
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.

    Dual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.

    The purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    23 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas: Assessing Tumor Perfusion and Prediction of Treatment Outcomes
    Actual Study Start Date :
    Apr 14, 2015
    Actual Primary Completion Date :
    Oct 1, 2018
    Actual Study Completion Date :
    Apr 15, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Patient

    Patients head and neck CT scans performed as standard of care done prior to radiation treatment and approximately 12 weeks following treatment, will be acquired in the dual-energy computed tomography (DECT) mode. Participants will have one additional scan, also in the DECT mode, 2 to 3 weeks after the start of their radiation treatment.

    Outcome Measures

    Primary Outcome Measures

    1. Correlate iodine quantification with the microvascular density in the biopsy specimen [up to 18 months]

    Secondary Outcome Measures

    1. Utility of dual-energy computerized tomography obtained during chemoradiation therapy to predict treatment response. [up to 18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years and older

    • untreated, histologically confirmed head and neck squamous cell carcinoma

    Exclusion Criteria:
    • paranasal sinus involvement of head and neck squamous cell carcinoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ottawa Hospital Ottawa Ontario Canada K1Y 4E9

    Sponsors and Collaborators

    • Ottawa Hospital Research Institute
    • GE Healthcare

    Investigators

    • Principal Investigator: Santanu Chakraborty, MD, OHRI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ottawa Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT02279459
    Other Study ID Numbers:
    • 20140728-01H
    First Posted:
    Oct 31, 2014
    Last Update Posted:
    Aug 6, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck

    Study Results

    No Results Posted as of Aug 6, 2020