Completed

A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT

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What is being tested

Cone Beam Computed Tomography (CT) Scan

Other
Who is being recruted

Neoplasms

+ Neoplasms by Site

+ Head and Neck Neoplasms

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorUniversity of Michigan Rogel Cancer Center
Last updated: August 29, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01661062
Principal SponsorUniversity of Michigan Rogel Cancer Center
Last updated: August 29, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Criteria

5 inclusion criteria required to participate
Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and neck
Patients must be recommended a treatment course of at least 30 radiation fractions
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 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
Show More Criteria
1 exclusion criteria prevent from participating
Patients must not have a history of prior radiation to the head or neck

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Michigan Comprehensive Cancer Center

Ann Arbor, United StatesOpen University of Michigan Comprehensive Cancer Center in Google Maps
CompletedOne Study Center