Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/20/2019 |
| Start Date: | May 31, 2019 |
| End Date: | June 30, 2020 |
| Contact: | Clifford G Robinson, M.D. |
| Email: | clifford.robinson@wustl.edu |
| Phone: | 314-362-8567 |
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.
(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.
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 spinal MRI 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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Clifford G Robinson, M.D.
Phone: 314-362-8567
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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