N/A
N=23
A Study Using Cone Beam CT for Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01661062 ↗Enrolled (actual)
23
Serious AEs
11.1%
Results posted
Oct 2014
Primary outcome: Primary: Rate of Movement of Normal Tissue
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cone Beam Computed Tomography (CT) Scan (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Movement of Normal Tissue |
— | — |
| PRIMARY Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate |
-0.26; -0.42; -0.57; -0.35; -0.42; -0.60 | — |
| SECONDARY Improvement of Image Quality |
— | — |
| SECONDARY The Median Delivered Dose of Radiation to the Parotid Gland |
32.4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01661062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.