Image Guided Adaptive Radiotherapy in the Head-and-neck Region (BART)

Image Guided Adaptive Radiotherapy Based on Elastic Image Registration for Improved Tumor Coverage and Reduction of Side Effect in Normal Tissues

Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans.

It is investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Radiation: Follow-up CT scans during week 3 and week 5 of treatment

Detailed Description

Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy (ART) concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans.

It is prospectively investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine. For that purpose 2 repeat CT scans are acquired during the radiotherapy course (week 3 and week 5 of radiotherapy). The Initial CT scan is "matched" to the follow-up CT-scan by means of deformable image registration.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with histo-pathologically verified malignancies in the head-and-neck without clinical signs of dissemination, who consented in radiotherapy or radio-chemotherapy.

Exclusion Criteria:

• previous radiation therapy for head-and-neck

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adaptive Radiotherapy; Follow-up CT scans during week 3 and week 5 of Treatment Image-guided adaptive Radiotherapy arm: Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed.

Radiation: Follow-up CT scans during week 3 and week 5 of treatment; Scheduled follow-up planning CT scan and re-optimisation of the intensity modulation radiation therapy (IMRT)-based radiotherapy Treatment plan. Dosimetric Evaluation and assessment of morphologic changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Planning Target Volume (PTV) Coverage Parameter D98%	Dose coverage of the planning target volume: Number of participants with a decrease in the planning target volume (PTV) coverage (D98%) above 5%. The Parameter "D98%" denotes the minimum dose to 98% of the volume according to the ICRU (International Commission on Radiation Units & Measurements) Report No. 62. It is a widely accepted classification index for dose coverage. The "Planing Target Volume" is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose.	week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric Changes	Percent changes in the volume of the Planning Target Volume (PTV). The "Planning Target Volume" is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose. The volumetric changes of the PTV throughout the course of Radiation therapy are evaluated. A significant change in the volume of the PTV (measured in ccm) might be an indicator for possible undesireable dosimetric alterations.	week 5

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Karin S Kapp, MD, Prof., Medical University of Graz

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: BART 1.1