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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279459
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Santanu Chakraborty, Ottawa Hospital Research Institute

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
Head and Neck Squamous Cell Carcinoma

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.

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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 : April 14, 2015
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Correlate iodine quantification with the microvascular density in the biopsy specimen [ Time Frame: up to 18 months ]

Secondary Outcome Measures :
  1. Utility of dual-energy computerized tomography obtained during chemoradiation therapy to predict treatment response. [ Time Frame: up to 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, aged 18 years and older with untreated, histologically confirmed head and neck squamous cell carcinoma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279459


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
GE Healthcare
Investigators
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Principal Investigator: Santanu Chakraborty, MD OHRI

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Responsible Party: Santanu Chakraborty, Principal Investigator, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02279459    
Other Study ID Numbers: 20140728-01H
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site