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Completed

NCT Number: NCT03878485

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.

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Key information

Conditions

Oligometastases of the Spine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRIdian Linac System from ViewRay

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

Other names: MR-linac

Stereotactic MRI-guided Adaptive Radiotherapy

Radiation

-The MR-linac will be delivering the radiation

Other names: SMART

Primary outcomes

  1. 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

    Time frame: First on-table attempt of first fraction of radiation (an average of 1 day)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 18, 2019
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.