Clinical trial NCT01661062: A Study Using Cone Beam CT for Head and Neck Cancer
Official title: A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Rate of Movement of Normal Tissue
timeFrame: approximately 7 weeks
measure: Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
timeFrame: 24 months
Secondary outcomes:
measure: Improvement of Image Quality
timeFrame: 36 months
measure: The Median Delivered Dose of Radiation to the Parotid Gland
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Avraham Eisbruch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunter KU, Fernandes LL, Vineberg KA, McShan D, Antonuk AE, Cornwall C, Feng M, Schipper MJ, Balter JM, Eisbruch A. Parotid glands dose-effect relationships based on their actually delivered doses: implications for adaptive replanning in radiation therapy of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):676-82. doi: 10.1016/j.ijrobp.2013.07.040. Epub 2013 Sep 10.