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| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
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The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions.
In the current study, a 2D-cine MRI examination will be performed, in addition to the 4D CT examination that is standard for patients receiving radiotherapy for tumours in the thorax or abdomen. A subgroup of the study participants (referred to as the 4D CBCT subcohort) will also be required to perform a 4D CBCT examination at three treatment sessions. The main cohort consists of 95 subjects and the 4D CBCT subcohort of 55 subjects. The study does not involve any change in the treatment routine; rather, the study images are collected for retrospective analysis. Following each imaging session, the subject should fill out an anxiety questionnaire and their pulse will be measured, to give an indication of any anxiety which might influence the breathing pattern of the current session.
Clinical follow-up will be performed retrospectively by reviewing the participants' medical records. Progress, health status and treatment-related toxicity will be evaluated, up to 10 years after completed treatment.
The study objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full cohort | Experimental | All subjects are included in the same arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic MRI | Other | Subjects receive a study-specific dynamic MRI scan. If the hypothesis of the study is confirmed, this examination can be used to inform future patients' treatment planning, replacing the use of 4D CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively | The two dynamic scans represent the tumour motion through different techniques. If the amplitude indicated by 4D CT is smaller than that indicated by dynamic MRI, the hypothesis is confirmed. | Over 3-4 weeks: twice pre-treatment, and three times during treatment |
| Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT) | 4D CBCT images are acquired at each treatment session, in treatment position. These will assess the stability of the breathing patter through the treatment course. | Over 3-4 weeks: twice pre-treatment, and three times during treatment |
| Difference in the structure of the probability density function, assessed at different times | The breathing pattern is represented by a probability density function, indicating the regularity of the motion. The stability of this pattern through the treatment course will be assessed. | Over 3-4 weeks: twice pre-treatment, and three times during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety during examinations of tumour motion | Measured by a questionnaire | Over 3-4 weeks: twice pre-treatment, and three times during treatment |
| Overall survival | Review of medical records |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mattias Hedman, MD PhD | Contact | +46812370000 | mattias.hedman@regionstockholm.se | |
| Eva Onjukka, PhD | Contact | eva.onjukka@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Eva Onjukka, PhD | Karolinska University Hospital/Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 10 years after treatment |
| Progression-free survival | Review of medical records | Up to 10 years after treatment |
| Grade ≥2 toxicity assessed by CTCAE v.5.0 | Review of medical records | Up to 10 years after treatment |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |