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

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).

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Other: Setup and Imaging for at CT radiation planning

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merina Ahmed; Phone Number: 02086426011; Email: merina.ahmed@rmh.nhs.uk

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PY
      • Recruiting
      • Royal Marsden NHS Foundation Trust
      • Contact: Bianca Peet; Phone Number: 02086613566; Email: bianca.peet@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supine; Patients undergo supine setup and imaging for radiation planning	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.
Experimental: Prone; Patients undergo prone setup and imaging for radiation planning	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CCR 5216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No