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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545322
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Radiation: Follow-up CT scans during week 3 and week 5 of treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image Guided Adaptive Radiotherapy Based on Elastic Image Registration for Improved Tumor Coverage and Reduction of Side Effect in Normal Tissues
Study Start Date : February 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545322


Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Karin S Kapp, MD, Prof. Medical University of Graz
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02545322    
Other Study ID Numbers: BART 1.1
First Posted: September 9, 2015    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms