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

Solid Tumor, Adult Clinical Trial

— IMPRESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05252975
• Other study ID #: CCR 5216
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2022
• Source: Royal Marsden NHS Foundation Trust
• Contact: Merina Ahmed
• Phone: 02086426011
• Email: merina.ahmed[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Other:
• Setup and Imaging for at CT radiation planning
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.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Organs at risk dose	Compare organs at risk dose between supine and prone positioning.	Immediate
Secondary	Comfort scores	Evaluate comfort scores in both treatment positions (supine and prone)	Immediate
Secondary	CT and MRI registration	Evaluate CT and MRI registration on tumour target delineation	Immediate
Secondary	Treatment time duration	Treatment time duration	Immediate