Oligometastases of the Spine
Conditions
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.
Interventions
DEVICEMRIdian Linac System from ViewRay
* 0.35T MRI combined with a linear accelerator * This device will be used for the Stereotactic MRI-guided Adaptive Radiotherapy
RADIATIONStereotactic MRI-guided Adaptive Radiotherapy
-The MR-linac will be delivering the radiation
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | First on-table attempt of first fraction of radiation (an average of 1 day) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Stereotactic MRI-guided Adaptive Radiotherapy |
|---|---|
| Age, Continuous | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stereotactic MRI-guided Adaptive Radiotherapy | 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 | 8 Participants |