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

NCT ID: NCT03878485

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2024-01-09

Brief Summary

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.

Conditions

Oligometastases of the Spine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

MRIdian Linac System from ViewRay

Intervention Type: DEVICE

• 0.35T MRI combined with a linear accelerator
• This device will be used for the Stereotactic MRI-guided Adaptive Radiotherapy

Stereotactic MRI-guided Adaptive Radiotherapy

Intervention Type: RADIATION

-The MR-linac will be delivering the radiation

Interventions

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

Intervention Type: DEVICE

Stereotactic MRI-guided Adaptive Radiotherapy

-The MR-linac will be delivering the radiation

Intervention Type: RADIATION

Other Intervention Names

MR-linac; SMART

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clifford Robinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201903023

Identifier Type: -

Identifier Source: org_study_id