Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)

Study Overview
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Brief Summary
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A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).

Detailed Description
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This is a prospective, non-randomised radiotherapy planning study. Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients. Patients continue to receive treatment in the proposed position as recommended y their treating physician.

Official Title
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Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Other: Setup and Imaging for at CT radiation planning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients undergoing Cyberknife treatment to spinal metastasis >18 years of age Thoracic, lumbar and sacral spinal metastasis Patients suitable to undergo radiotherapy planning CT scans in the prone position (treating physician assessed as having spinal stability). All solid tumour types will be eligible Exclusion Criteria: • Primary spinal tumours Vertebral disease resulting in unstable spinal vertebrae Cervical tumours (patients will be unable to have a thermoplastic shell made for the prone position). Patients with significant pain on prone lying (to be assessed by physician prior to consent) Bilsky epidural score of 2 or greater (see appendix 1) Pre-existing musculoskeletal chronic back medical diagnoses that would preclude CT scanning in the prone position.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supine<br>Patients undergo supine setup and imaging for radiation planning | Other: Setup and Imaging for at CT radiation planning<br>* Patients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans.<br>|
| Experimental: Prone<br>Patients undergo prone setup and imaging for radiation planning | Other: Setup and Imaging for at CT radiation planning<br>* Patients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTV isodose coverage | To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organs at risk dose | Compare organs at risk dose between supine and prone positioning. | Immediate | 
| Comfort scores | Evaluate comfort scores in both treatment positions (supine and prone) | Immediate | 
| CT and MRI registration | Evaluate CT and MRI registration on tumour target delineation | Immediate | 
| Treatment time duration | Treatment time duration | Immediate |