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

NCT05252975 | Unknown

• 1 other identifier: CCR 5216
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Organs at risk dose

  Immediate

• Comfort scores

  Immediate

• CT and MRI registration

  Immediate

• Treatment time duration

  Immediate

Study Arms (2)

Supine

ACTIVE COMPARATOR

Patients undergo supine setup and imaging for radiation planning

Other: Setup and Imaging for at CT radiation planning

Prone

EXPERIMENTAL

Patients undergo prone setup and imaging for radiation planning

Other: Setup and Imaging for at CT radiation planning

Interventions

Setup and Imaging for at CT radiation planning OTHER

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.

Prone; Supine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PY, United Kingdom

RECRUITING

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Merina Ahmed

CONTACT

02086426011; merina.ahmed@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 23, 2022
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)