Clinical trial NCT03878485: Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
Official title: Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligometastases of the Spine
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.
* 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.

Primary outcomes:
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
timeFrame: First on-table attempt of first fraction of radiation (an average of 1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Clifford Robinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: