CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
MRIdian Linac System from ViewRay +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03878485
NCT03878485N/ACompleted

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

Washington University School of Medicine·interventional·Posted Mar 18, 2019·Updated Jul 25, 2024

In Brief

A clinical study evaluating MRIdian Linac System from ViewRay and Stereotactic MRI-guided Adaptive Radiotherapy for Oligometastases of the Spine. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 18, 2019
Enrollment StartNov 6, 2019
Primary CompletionOct 9, 2023
Study CompletionJan 9, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.3 years ago

Interventions

MRIdian Linac System from ViewRaydevice

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

Stereotactic MRI-guided Adaptive Radiotherapyradiation

-The MR-linac will be delivering the radiation