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

Royal Marsden NHS Foundation Trust10 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult

Interventions

Setup and Imaging for at CT radiation planningOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

PTV isodose coverage

To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions

Time frame: Through study completion, an average of 1 year.

Secondary Outcomes

Organs at risk dose

Compare organs at risk dose between supine and prone positioning.

Time frame: Immediate

Comfort scores

Evaluate comfort scores in both treatment positions (supine and prone)

Time frame: Immediate

CT and MRI registration

Evaluate CT and MRI registration on tumour target delineation

Time frame: Immediate

Treatment time duration

Time frame: Immediate

Central Contacts

Merina Ahmed

CONTACT

02086426011 merina.ahmed@rmh.nhs.uk

Data from ClinicalTrials.gov

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