Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine

In light of the increasing experience with magnetic resonance image-guided radiotherapy (MRgRT) and adaptive planning and advances in magnetic resonance (MR)-only planning, the investigators propose here to evaluate the feasibility and safety of same-session MR-only simulation and treatment with SMART for spinal metastases. Although spine SBRT is a standard-of-care treatment modality, this expedited same-session MR-only simulation and treatment with SMART workflow is novel. Previously, delivery of spine SBRT has typically required several days from time of consultation to simulation and then 1-2 weeks from simulation to the initiation of treatment. On this proposed study, patients will not undergo computed tomography (CT) simulation and will instead have same-session MR-only simulation and treatment planning, on-table, using SMART. In this manner, patients would initiate treatment within just several days from the consult. Feasibility of the workflow will be defined as successful delivery of the first fraction of same-session MRI-only simulation and treatment with SMART on the first on-table attempt for at least 70% of patients. Patients will be treated in five fractions over 1-2 weeks. Although the long-term goal will be to achieve a significantly shortened time from consult to treatment as compared to traditional stereotactic body radiation therapy (SBRT) using simulation, the present study will be driven by short-term goals of workflow feasibility and safety.

Study Overview

• Status: Completed
• Conditions: Oligometastases of the Spine
• Intervention / Treatment: Device: MRIdian Linac System from ViewRay; Radiation: Stereotactic MRI-guided Adaptive Radiotherapy

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

Contacts and Locations

• Study Contact: Name: Clifford Robinson, M.D.; Phone Number: 314-362-8567; Email: clifford.robinson@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least one disease site deemed to be suitable for treatment with spine SBRT as per radiation oncology evaluation.
• Karnofsky Performance Status (KPS) ≥ 60.
• Deemed medically fit for SBRT by treating physician
• Diagnostic CT with images through the projected treatment area within six months prior to enrollment.
• At least 18 years of age.
• Ability to understand and willingness to sign an IRB approved written informed

Exclusion Criteria:

• Past history of radiotherapy within the projected treatment field to be treated by MRI-guided SBRT
• Medical contraindication to undergoing MR imaging.
• Spine metastasis resulting in symptomatic spinal cord compression.
• Any other condition that, in the opinion of the treating radiation oncologist, renders the patient unfit for SBRT.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic MRI-guided Adaptive Radiotherapy; -Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).	Device: MRIdian Linac System from ViewRay; 0.35T MRI combined with a linear accelerator; This device will be used for the Stereotactic MRI-guided Adaptive Radiotherapy; Other Names: MR-linac; Radiation: Stereotactic MRI-guided Adaptive Radiotherapy; -The MR-linac will be delivering the radiation; Other Names: SMART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants to receive delivery of the first fraction of same-session MRI-only simulation and treatment with SMART on the first on-table attempt	Completion of first fraction of treatment for all enrolled participants (estimated to be 48 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Clifford Robinson, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): October 9, 2023
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201903023

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: Yes
• product manufactured in and exported from the U.S.: No