A Study Using Cone Beam CT for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01661062
• Other study ID #: 2005.084
• Secondary ID: HUM 757
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2011
• Last updated: August 28, 2015
• Start date: January 2009
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: June 2016
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Cone Beam Computed Tomography (CT) Scan
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.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Movement of Normal Tissue	The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.	approximately 7 weeks	No
Primary	Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate	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).	24 months	No
Secondary	Improvement of Image Quality	Use acquired data to further improve cone beam CT reconstruction techniques and image quality.	36 months	No
Secondary	The Median Delivered Dose of Radiation to the Parotid Gland		7 weeks	No