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 (RESONATE)

The Christie NHS Foundation Trust

Status: Enrolling

Conditions: Metastatic Spinal Cord Compression

Treatments: Radiation: Radiotherapy to the spine in a single appointment

Study type: Interventional

Funder types: Other

Identifiers

NCT06965101

CFTSp246

Details and patient eligibility

About

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.

Full description

Metastatic cord compression occurs in 5-10% of patients with cancer often affected the ends stages of a patient's illness. The benefit of palliation is directly related to the speed of treatment, National Institute of Health and Care Excellence (NICE) guidelines recommend that radiotherapy is given within 24 hours of a decision to treat. A recent audit of the current referrals and pathway showed the average time from consultation to treatment is 2.10 days (SD 12.2 days). This audit concluded the need to improve the speed of access to care.

The current pathway includes a scan for diagnosis (MRI), a visit for a planning CT and time to plan the treatment before treatment delivery. This can take many hours or even days. To provide quicker access to care it is intended to use the MR Linac with an integrated adaptive radiotherapy platform, to deliver a scan, plan and treat model in a single appointment.

Preliminary work has modelled dose differences due to the presence of a magnetic field, known as the electron return effect and developed an MR only workflow using a simple planning technique to enable the online scan, plan and treat model.

The primary objective is to test the feasibility of a one-stop MR guided palliative radiotherapy programme for patients with MSCC.

Secondary objectives are:

• To reduce overall time from decision to treat to treatment delivery.
• Reduce the number of appointments and procedure required to provide palliative radiotherapy for patients with MSCC.
• Compare participant experience of MSCC treatment on the MR Linac to the current standard of care pathway.

This is a single centre, non-randomised clinical trial. All patients referred for radiotherapy to treat MSCC who can provide informed consent can be considered. Participants will be asked to have treatment on the MR Linac within a single appointment and complete an experience questionnaire. If participants would not like to have treatment on the MRL or do not meet the inclusion criteria participants can continue the standard of care pathway with the addition of completing an experience questionnaire and the data and answers will be used for analysis. If patients would not like to participate, standard of care radiotherapy will be delivered and this patient data will not be used for this study.

The study is expected to recruit up to 72 participants over a 2-year period using a 1:2 ratio. Up to 24 participants will be recruited to the MR Linac Arm of the study. This sample is based on resource constraints, the MR Linac can accommodate one patient per month on average. Recruitment will be a 1:2 ratio to reduce bias to the investigational arm.

To test the aim, to improve the speed of access of care, timings will be collected at certain time points throughout the pathway:

• Clinical decision to treat the participant
• Time of treatment consent
• Time of Radiotherapy Planning scan (Standard of Care only)
• Time of Radiotherapy Completion

The study will consist of:

1. MSCC team confirm diagnosis & organise for the patient to be transferred to the Christie. (Day 0)
2. Referral to Radiotherapy (Day 0)
3. Approached in person by the Research Team & MRI screening. (Day 1)
4. Consent to Radiotherapy. (Day 1)
5. Consent to Study. (Day 1)
6. Optional Equality diversity and inclusivity (EDI) Questionnaire completed. (Day1)
7. Patient prepared in MRL clinical system or given RTP appointment. (Day 1)
8. Radiotherapy treatment on MRL or Conventional Linac. (Day 1 -7)
9. Patient experience questionnaire completed. (Same day as treatment)
10. Patient outcomes will be determined from clinical notes. (1,3,6,12 months following treatment)

A participant is free to withdraw from the clinical trial at any point without giving a reason.

This study will run for 3 years in total, 2 years for recruitment plus one year for follow up unless early termination is required.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed Diagnosis of MSCC
• Referred for an 8Gy, Single Fraction of Radiotherapy
• 18 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

Exclusion criteria

• 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.

Exclusion Criteria MRL arm:

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups, including a placebo group

MRL

Active Comparator group

Description:

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

Treatment:

Radiation: Radiotherapy to the spine in a single appointment

Standard of Care

Placebo Comparator group

Description:

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.

Treatment:

Radiation: Radiotherapy to the spine in a single appointment