MRIdian "RADAR" Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants ages ≥ 18.
Solid tumors causing MESCC for which surgery is an option as first-line treatment.
Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria.
MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement.
Disqualifiers
Unknown primary histology
Patients with rapid neurologic decline.
Bony retropulsion causing neurologic abnormality
Non-ambulatory patients.
Trial design
Design model
Single group
Treatments tested in this trial
ViewRay MRIdian Stereotactic Radiosurgery
RadiationParticipants will undergo stereotactic radiosurgery of the spinal cord on the ViewRay MRIdian, a hybrid MRI-linac platform, with 40 Gy in 5 fractions prescribed to the planning target volume (PTV).
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: ViewRay MRidianExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
One-year failure rate
The one-year failure rate is determined by the number of study participants with clinical failure, defined as needing decompressive surgery at the targeted spinal area due to progression of disease. The rate is determined by the amount of participants with documented clinical failure at any time within ten months of completing protocol therapy. This number is compared to the rate of decompressive surgery in the general population.
Time frame
Up to 1 yearSecondary outcomes
1
Rate of radiation myelopathy
The rate of radiation myelopathy will assess the proportion of patients with neurologic deterioration prior to starting protocol therapy to six months after completing protocol therapy. This is determined using the modified McKenzie scores and will be scored by the treating physician. Scores are A: no abnormality, B: focal minor symptom (e.g. pain), C: functional paresis, D: nonfunctional paresis, and E: paralysis or incontinence. The treating physician will determine if scores are probably or definitely related to protocol therapy and not to local progression of tumor.
Time frame
Up to 6 months2
Rate of vertebral compression fracture
The rate of vertebral compression fracture (VCF) is determined by the number of participants who develop VCF possibly, probably, or definitely related to the protocol therapy, as opposed to tumor progression. This is assessed and determined by the treating physician by reviewing the initial MRI done prior to starting protocol therapy compared to MRI scans done at follow up visits after receiving protocol therapy.
Time frame
Up to 2 years3
Number of Treatment Related Adverse Events as Measured By CTCAE v.5
The number of treatment-related adverse events during the study will be assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 3 months of completing the protocol therapy that are determined to be grades 2 or higher (acute toxicity) by the treating physician.
Time frame
Up to 1 year4
Local control (LC) rate
The local control (LC) is defined as the absence of progression of the disease at the treated spinal area. The LC rate is assessed by comparing two separate MRI scans - the initial MRI done prior to starting therapy compared to the MRI done one month after completing protocol therapy. The rate is determined by assessing progression of disease between the two MRI scans.
Time frame
Up to 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
Viewray Inc.
Collaborator
Source ClinicalTrials.gov
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