Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Radiotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karin S Kapp, MD, Prof. | Medical University of Graz | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | week 5 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Winkler, PhD (Head of Medical Physics) | Department of Therapeutic Radiology and Oncology, Medical University of Graz | +43 316 385 | 83193 | peter.winkler@medunigraz.at |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| week 5 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent | week 5 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
Not provided