Trial Information

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

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.