Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Laryngeal Diseases

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

computed tomography

cone-beam computed tomography

radiography

Undergo 2-D x-ray with Brain Lab ExacTrac

electronic portal imaging

image-guided adaptive radiation therapy

Joshua Evans, PhD

This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment. It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy. Comparing results of imaging procedures done before, during, and after radiotherapy may help doctors plan the best treatment.

I. To conduct a clinical imaging study utilizing three novel in-room imaging systems: Oblique Brainlab ExacTrac images, Orthogonal Varian kilovoltage (kV) On-board Imaging (OBI) image, and Varian cone-beam computed tomography (CBCT) imaging to assess their performance in reducing inter- and intrafractional setup errors, relative to weekly megavoltage (MV) electronic portal imaging device (EPID) images, using both bony landmarks and soft tissue changes for head and neck cancer (HNC) patients undergoing external beam radiation therapy (RT).

II. To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in the head and neck (HN) area relative to conventional high resolution contrast enhanced fan-beam computed tomography (CT) (FBCT) as a standard.

III. To assess the systematic and random soft tissue motion errors using daily CBCT imaging relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during radiotherapy.

IV. To quantify soft tissue changes during an entire course of radiotherapy (e.g. tumor shrinkage) using daily CBCT imaging.

V. To determine the feasibility of using measured set up and soft-tissue motion uncertainties in conjunction with volume changes observed on serial CBCT images, for offline adaptive replanning of HNC patients using available planning tools.

VI. To quantify the benefits of adaptive image-guided radiotherapy (IGRT) in HN patients in terms of target coverage and normal tissue avoidance.

VII. To determine the feasibility of mounting a phase I/II trial to assess the clinical benefits of image-guided adaptive radiotherapy (IGART) in terms of acute and late toxicities and tumor control.

VIII. To build a HNC patient database for future validation of IGART processes using deformable image registration and Virtual Clinical Trials (VCTs).

OUTLINE:

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-dimensional (2-D) x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer

Image-Guided Adaptive Radiotherapy for Head And Neck Cancer: Patient Image Acquisition

The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.

Virginia Commonwealth University

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

computed tomography: Undergo FBCT

cone-beam computed tomography: Undergo dual CBCT

radiography: Undergo 2-D x-ray with Varian kV OBI

radiography: Undergo 2-D x-ray with Brain Lab ExacTrac

radiography: Undergo 2-D x-ray with Varian MV OBI

electronic portal imaging: Undergo EPID imaging

image-guided adaptive radiation therapy: Undergo IGART

Diagnostic (Imaging Technology)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Joshua Evans, Ph.D.

Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.

Vertical shift

Lateral shift

Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.

Orthogonal Varian kV OBI Image

Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.

Varian CBCT (Cone Beam CT) Imaging

Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.

Oblique Brainlab ExacTrac Images

Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.

Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies

No data analyzed due to staff leaving primary institution.

Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%

Greater Than or Equal to 5% Variation of Normal Tissue Toxicity

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART

Spots Global Cancer Trial Database for electronic portal imaging