- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01661062
A Study Using Cone Beam CT for Head and Neck Cancer
July 26, 2016 updated by: University of Michigan Rogel Cancer Center
A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT
Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A
CT scan uses x-rays to produce detailed pictures of structures in the body.)
In this study, cone beam CT scans will be obtained before individual radiation treatment sessions for head and neck cancer.
The information gathered from these scans will be used by the researchers to look at patient movement as well as changes in the amount of normal and tumor tissue throughout the course of radiation therapy.
The researchers will use this information to create hypothetical radiation treatment plans, which will be used as the basis for future research.
The cone beam CT scan data will not be used to alter the actual radiation treatment of any of the patients enrolled on the study.
In addition, tests of salivary output and swallowing and questionnaires about quality of life will be made to assess how the doses of radiation affect them.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients of all ages ≥18, both sexes, and all races will be included in this study. Pregnant females will be excluded. No other special classes of subjects (i.e., prisoners) will be entered.
- Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and neck.
- Patients must be recommended treatment with definitive radiation therapy with concurrent chemotherapy, but without prior surgical resection of the primary tumor or lymph nodes
- Patients must be recommended a treatment course of at least 30 radiation fractions
- Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Hospital indicating that they are aware that undergoing cone beam CT of the head and neck is voluntary and has potential risks.
Exclusion Criteria:
- Patients must not have a history of prior radiation to the head or neck
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cone Beam CT
All patients will be included in the treatment arm of this study.
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Although the exact amount of radiation patients get will be determined by their doctor, it is expected that they will get approximately 7 weeks, approximately 35 total cone beam CT scans.
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Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body).
It will add a small amount of additional radiation dose (less than 1%) to the head and neck.
The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive.
The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Movement of Normal Tissue
Time Frame: approximately 7 weeks
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The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
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approximately 7 weeks
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Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
Time Frame: 24 months
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Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Image Quality
Time Frame: 36 months
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Use acquired data to further improve cone beam CT reconstruction techniques and image quality.
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36 months
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The Median Delivered Dose of Radiation to the Parotid Gland
Time Frame: 7 weeks
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7 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Avraham Eisbruch, MD, University of Michigan Rogel Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 26, 2011
First Submitted That Met QC Criteria
August 6, 2012
First Posted (Estimate)
August 9, 2012
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
July 26, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005.084
- HUM 757 (Other Identifier: University of Michigan IRBMED)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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