Oligometastases of the SpineNCT03878485
Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
A study testing MRIdian Linac System from ViewRay and Stereotactic MRI-guided Adaptive Radiotherapy in people with Oligometastases of the Spine, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastases of the Spine
- What is being tested?
- MRIdian Linac System from ViewRay and Stereotactic MRI-guided Adaptive Radiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Oligometastases of the Spine
- Being tested
- MRIdian Linac System from ViewRay, Stereotactic MRI-guided Adaptive Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIdian Linac System from ViewRayDevice
Also called MR-linac
- 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
Also called SMART
-The MR-linac will be delivering the radiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic MRI-guided Adaptive Radiotherapy | Experimental | -Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected). Receives: Device: MRIdian Linac System from ViewRay; Radiation: Stereotactic MRI-guided Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First on-table attempt of first fraction of radiation (an average of 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start6 Nov 2019
- Primary completion9 Oct 2023
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oligometastases of the SpineStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clifford Robinson, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878485
- Sponsor's protocol ID
- 201903023
- Status last verified
- Jul 2024
- First submitted
- 14 Mar 2019
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
- ClinicalTrials.gov ID
- NCT03878485
- Acronym / sponsor ID
- 201903023
- Conditions
- Oligometastases of the Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic MRI-guided Adaptive Radiotherapy | Experimental | Device: MRIdian Linac System from ViewRay, Radiation: Stereotactic MRI-guided Adaptive Radiotherapy-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- At least 18 years of age.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIdian Linac System from ViewRayAlso: MR-linac* 0.35T MRI combined with a linear accelerator * This device will be used for the Stereotactic MRI-guided Adaptive Radiotherapy | Device | Stereotactic MRI-guided Adaptive Radiotherapy |
| Stereotactic MRI-guided Adaptive RadiotherapyAlso: SMART-The MR-linac will be delivering the radiation | Radiation | Stereotactic MRI-guided Adaptive Radiotherapy |
Primary outcome
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: First on-table attempt of first fraction of radiation (an average of 1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifford Robinson, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRIdian Linac System from ViewRay and Stereotactic MRI-guided Adaptive Radiotherapy in people with Oligometastases of the Spine, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: First on-table attempt of first fraction of radiation (an average of 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.