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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05252975
Acronym
IMPRESS
Enrollment
10
Registered
2022-02-23
Start date
2020-07-01
Completion date
2023-04-01
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Adult

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).

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.

Interventions

OTHERSetup 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.

Sponsors

Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
PTV isodose coverageThrough study completion, an average of 1 year.To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions

Secondary

MeasureTime frameDescription
Organs at risk doseImmediateCompare organs at risk dose between supine and prone positioning.
Comfort scoresImmediateEvaluate comfort scores in both treatment positions (supine and prone)
CT and MRI registrationImmediateEvaluate CT and MRI registration on tumour target delineation
Treatment time durationImmediateTreatment time duration

Countries

United Kingdom

Contacts

Primary ContactMerina Ahmed
merina.ahmed@rmh.nhs.uk02086426011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026