Image Guided Adaptive Radiotherapy in the Head-and-neck Region

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up CT scans during week 3 and week 5 of treatment

Radiation

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.

Primary outcomes

Planning Target Volume (PTV) Coverage Parameter D98%

Time frame: week 5

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.

Secondary outcomes

Volumetric Changes

Time frame: week 5

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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: BART

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Sep 9, 2015
Registry last updated: Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed