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

  • STATUS
    Recruiting
  • End date
    Nov 6, 2023
  • participants needed
    10
  • sponsor
    Washington University School of Medicine
Updated on 7 July 2022

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.

Details
Condition Oligometastases of the Spine
Treatment MRIdian Linac System from ViewRay, Stereotactic MRI-guided Adaptive Radiotherapy
Clinical Study IdentifierNCT03878485
SponsorWashington University School of Medicine
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

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
Diagnostic PET/CT, CT, or MRI with images through the projected treatment area obtained less than or equal to six weeks 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
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