Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
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ClinicalTrials.gov Identifier: NCT03878485 |
Recruitment Status :
Recruiting
First Posted : March 18, 2019
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment | Phase |
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Oligometastases of the Spine | Device: MRIdian Linac System from ViewRay Radiation: Stereotactic MRI-guided Adaptive Radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine |
Actual Study Start Date : | November 6, 2019 |
Estimated Primary Completion Date : | November 6, 2021 |
Estimated Study Completion Date : | November 6, 2021 |
Arm | Intervention/treatment |
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Experimental: Stereotactic MRI-guided Adaptive Radiotherapy
-Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
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Device: MRIdian Linac System from ViewRay
Other Name: MR-linac Radiation: Stereotactic MRI-guided Adaptive Radiotherapy -The MR-linac will be delivering the radiation
Other Name: SMART |
- 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: Completion of first fraction of treatment for all enrolled participants (estimated to be 24 months) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878485
Contact: Lauren Henke, M.D., M.S.C.I. | 314-747-4405 | henke.lauren@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Lauren Henke, M.D., M.S.C.I. 314-747-4405 henke.lauren@wustl.edu | |
Principal Investigator: Lauren Henke, M.D., M.S.C.I. | |
Sub-Investigator: Clifford G Robinson, M.D. | |
Sub-Investigator: Soumon Rudra, M.D. | |
Sub-Investigator: Olga Green, Ph.D. | |
Sub-Investigator: Justin Park, Ph.D. |
Principal Investigator: | Lauren Henke, M.D., M.S.C.I. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT03878485 |
Other Study ID Numbers: |
201903023 |
First Posted: | March 18, 2019 Key Record Dates |
Last Update Posted: | November 13, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |