NCT03878485

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

Completed NA Results posted Last updated 25 July 2024

What this trial tests

NA trial testing MRIdian Linac System from ViewRay in Oligometastases of the Spine in 10 participants. Completed in 9 January 2024.

Timeline

6 November 2019

Primary endpoint
9 October 2023

9 January 2024

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	6 November 2019
Primary completion	9 October 2023
Estimated completion	9 January 2024
Sites	1 location across United States

Drugs / interventions tested

• MRIdian Linac System from ViewRay
• Stereotactic MRI-guided Adaptive Radiotherapy

Conditions studied

• Oligometastases of the Spine — all drugs for Oligometastases of the Spine →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Oligometastases of the Spine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · First on-table attempt of first fraction of radiation (an average of 1 day)

Group	Value	95% CI
Stereotactic MRI-guided Adaptive Radiotherapy	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stereotactic MRI-guided Adaptive Radiotherapy

Serious: 2/10 (20%)

Deaths: 1/10

Serious adverse events (3 terms)

Reaction	System	Stereotactic MRI-guided Ad…
Back pain	Musculoskeletal and connective tissue disorders	—
Abdominal pain	Gastrointestinal disorders	—
Disease progression	General disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Stereotactic MRI-guided Ad…
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—

Most-reported serious reactions: Back pain, Abdominal pain, Disease progression.

Data from ClinicalTrials.gov NCT03878485 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stereotactic Magnetic Resonance-Guided Adaptive and Non-Adaptive Radiotherapy on Combination MR-Linear Accelerators: Current Practice and Future Directions.
   Bryant JM, Weygand J, Keit E, Cruz-Chamorro R, et al · · 2023 · cited 24× · PMID 37046741 · DOI 10.3390/cancers15072081
2. Patterns of utilization and clinical adoption of 0.35 Tesla MR-guided radiation therapy in the United States - Understanding the transition to adaptive, ultra-hypofractionated treatments.
   Chuong MD, Clark MA, Henke LE, Kishan AU, et al · · 2023 · cited 16× · PMID 36466748 · DOI 10.1016/j.ctro.2022.11.013
3. A pilot study of same-day MRI-only simulation and treatment with MR-guided adaptive palliative radiotherapy (MAP-RT).
   Schiff JP, Maraghechi B, Chin RI, Price A, et al · · 2023 · cited 14× · PMID 36594078 · DOI 10.1016/j.ctro.2022.100561
4. Treatment of Central Nervous System Tumors on Combination MR-Linear Accelerators: Review of Current Practice and Future Directions.
   Bryant JM, Doniparthi A, Weygand J, Cruz-Chamorro R, et al · · 2023 · cited 6× · PMID 37958374 · DOI 10.3390/cancers15215200
5. Initial clinical experience building a dual CT- and MR-guided adaptive radiotherapy program.
   Price AT, Schiff JP, Laugeman E, Maraghechi B, et al · · 2023 · cited 4× · PMID 37529627 · DOI 10.1016/j.ctro.2023.100661
6. MRI-Guided Radiation Therapy.
   Lee SL, Hall WA, Morris ZS, Christensen L, et al · · 2021 · cited 1× · PMID 37064601 · DOI 10.1016/j.yao.2021.02.003
7. Initial experience with MR-guided adaptive spinal stereotactic radiotherapy: a new indication for the MR-linac.
   Dincer N, Zoto Mustafayev T, Atahan C, Gungor G, et al · · 2025 · PMID 40295375 · DOI 10.1007/s00066-025-02401-3