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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
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Oligometastases of the Spine Device: MRIdian Linac System from ViewRay Radiation: Stereotactic MRI-guided Adaptive Radiotherapy Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
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.
 Device: MRIdian Linac System from ViewRay
  • 0.35T MRI combined with a linear accelerator
  • This device will be used for the Stereotactic MRI-guided Adaptive Radiotherapy
Other Name: MR-linac

Radiation: Stereotactic MRI-guided Adaptive Radiotherapy
-The MR-linac will be delivering the radiation
Other Name: SMART


Outcome Measures
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Primary Outcome Measures :
  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: Completion of first fraction of treatment for all enrolled participants (estimated to be 24 months) ]

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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lauren Henke, M.D., M.S.C.I. 314-747-4405 henke.lauren@wustl.edu

Locations
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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.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Lauren Henke, M.D., M.S.C.I. Washington University School of Medicine
More Information
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Additional Information:

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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

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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