To Determine Whether it is Feasible to Treat Patients Requiring Urgent Radiotherapy Diagnosed With Metastatic Cord Compression (MSCC) on the Magnetic Resonance Linear Accelerator (MRL) in a Single Appointment and Compare it to the Standard of Care Radiotherapy Pathway

NCT06965101 | Recruiting

• 1 other identifier: CFTSp246
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand whether the Magnetic Resonance Linear Accelerator (MRL) could expedite Radiotherapy treatment for Metastatic Cord Compression (MSCC) by removing the need for a planning CT (pCT) scan prior to treatment. Radiotherapy will be delivered in one appointment on the MRL and compared to the standard of care of two appointments: a CT scan and a Radiotherapy appointment. The main questions it aims to answer are:

• Can the MRL deliver successful treatment of MSCC in a single 1-hour appointment?
• Can the MRL treat participants within 24 hours from the doctor's decision to treat?
• Did it take less time from consent to completion of treatment when patients were treated on the MRL?
• Do the questionnaire scores reflect satisfaction with treatment on the MRL? Researchers will compare treatment on the MRL in one appointment to a group receiving standard of care radiotherapy in two appointments. Participants in both groups will receive the same prescription of 8Gray (Gy) in one treatment (fraction) delivered with one posterior-anterior beam as per our department policies and national standards. Participants will be asked to complete an optional questionnaire prior to treatment to monitor the diversity of the study population. This questionnaire is anonymised, no personal data that could identify a participant is collected on this questionnaire. After treatment participants will be asked to complete an experience questionnaire, to assess treatment experience. Once the questionnaire is complete active participation in the trial is no longer needed, researchers will monitor participants notes for up to 12 months after treatment to record participant well being and function.

Conditions

Metastatic Spinal Cord Compression

Keywords

Radiotherapy; MR Linac; MSCC; CT Sim Free; One Stop; MR Guided

Outcome Measures

Primary Outcomes (1)

• Successful treatment of Metastatic Spinal Cord Compression in a single 1 hour appointment for 80% of patients on the MRL Arm

  "Successful treatment" is defined as the complete delivery of the Radiotherapy treatment beam to the area of Metastatic Spinal Cord Compression. The measurement used to assess appointment length will be time, recorded in hours, minutes and seconds. Time from the patient entering the room to the treatment beam completing.

  The event is assessed on a single day (within 24hours) over a single appointment. From the time the patient enters the treatment room to the time the radiotherapy beam is completed (Up to 2 hours in length).

Secondary Outcomes (4)

• 80% of patients on the MRL Arm treated within 24 hours from decision to treat

  From clinician's referral to the completion of the treatment beam (Assessed for up to 7 days).

• 80% of patients on the MRL Arm spend less time from consent to completion of treatment when compared to the Standard of Care Arm

  From time of treatment consent to completion of the treatment beam (Assessed for up to 7 days)

• 80% of the MRL Arm questionnaire scores reflect satisfaction with the treatment

  After completion of Radiotherapy (Within 2 hours of the treatment beam being completed)

• The study population is representative of the population referred for Radiotherapy for Metastatic Spinal Cord Compression.

  At the time of enrolment (within 2 hours of signing consent form)

Study Arms (2)

MRL

ACTIVE COMPARATOR

Using the MR Linac to deliver Radiotherapy in a single treatment without the need for a prior planning CT scan.

Radiation: Radiotherapy to the spine in a single appointment

Standard of Care

PLACEBO COMPARATOR

Using a conventional linear accelerator to deliver Radiotherapy in a single treatment, participants will require a prior planning CT appointment before Radiotherapy can be delivered.

Radiation: Radiotherapy to the spine in a single appointment

Interventions

Radiotherapy to the spine in a single appointment RADIATION

8Gy/ 1# to be delivered to all participants using a single posterior direct field.

MRL; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Diagnosis of MSCC
• Referred for an 8Gy, Single Fraction of Radiotherapy
• years or older.
• Able to give informed consent in writing or verbally.
• Willing to complete patient experience questionnaire
• Willing to have the research team review their case notes for up to 1 year following

You may not qualify if:

• Participant does not have capacity and cannot give informed consent.
• Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.
• Participant is unwilling to allow researchers to access their clinical notes and diagnostic scans.
• Participant is unwilling to complete an experience questionnaire
• The participant cannot speak or understand English.
• Any contraindications to MRI identified after MRI safety screening
• Unable to tolerate MRI scanning
• Uncontrolled pain/ poor pain control.
• MSCC in the cervical spine.
• More than one vertebral level of compression

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Publications (4)

• Olausson K, Holst Hansson A, Zackrisson B, Edvardsson D, Ostlund U, Nyholm T. Development and psychometric testing of an instrument to measure the patient's experience of external radiotherapy: The Radiotherapy Experience Questionnaire (RTEQ). Tech Innov Patient Support Radiat Oncol. 2017 Jul 24;3-4:7-12. doi: 10.1016/j.tipsro.2017.06.003. eCollection 2017 Sep-Dec.

  PMID: 32095560 BACKGROUND

• Barnes H, Alexander S, Bower L, Ehlers J, Gani C, Herbert T, Lawes R, Moller PK, Morgan T, Nowee ME, Smith G, van Triest B, Tyagi N, Whiteside L, McNair H. Development and results of a patient-reported treatment experience questionnaire on a 1.5 T MR-Linac. Clin Transl Radiat Oncol. 2021 Jun 29;30:31-37. doi: 10.1016/j.ctro.2021.06.003. eCollection 2021 Sep.

  PMID: 34307911 BACKGROUND

• Hales RB, Rodgers J, Whiteside L, McDaid L, Berresford J, Budgell G, Choudhury A, Eccles CL. Therapeutic Radiographers at the Helm: Moving Towards Radiographer-Led MR-Guided Radiotherapy. J Med Imaging Radiat Sci. 2020 Sep;51(3):364-372. doi: 10.1016/j.jmir.2020.05.001. Epub 2020 Jun 26.

  PMID: 32600981 BACKGROUND

• Benson R, Clough A, Nelder C, Pitt E, Portner R, Vassiliou M, McDaid L, Choudhury A, Rembielak A, Eccles C. Evaluation of the palliative radiotherapy pathway in a single institute: Can an MR Linac improve efficiency? J Med Imaging Radiat Sci. 2022 Jun;53(2 Suppl):S44-S50. doi: 10.1016/j.jmir.2021.11.010. Epub 2021 Dec 16.

  PMID: 34922879 BACKGROUND

Related Links

• NICE Guideline NG234 - Spinal Metastasis and Metastatic Spinal Cord Compression

MeSH Terms

Conditions

Spinal Cord Compression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries

Study Officials

• Cynthia L Eccles

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Radiographer

CONTACT

+441614468386; the-christie.radiotherapyclinicaltrials@nhs.net

Alice Greenwood-Wilson

CONTACT

+441614468386; alice.greenwoodwilson@nhs.net

Study Design

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

Model Details: Non Randomised, single centre study design. Participants will choose, if they meet all eligibility criteria, which treatment group they would like to participate in. Either to receive Radiotherapy on the MR Linac or standard of care Radiotherapy. If participants do not meet the eligibility criteria and would like to participate they will be assigned to the standard of care Radiotherapy group.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 11, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 4, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)