Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

Study Overview
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Brief Summary
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The purpose of this study is to determine if quantitative magnetic resonance imaging (qMRI) can objectively measure changes in the tumor/vertebral body and adjacent spinal cord following stereotactic body radiation therapy (SBRT) for painful metastatic spine disease.

Detailed Description
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Metastatic spine disease (MSD) can result in considerable morbidity from pain, spinal cord compromise and neurologic disability. Recent developments in image-guidance and immobilization have enabled more accurate target localization, which allows methods of precise high-dose radiation delivery such as stereotactic body radiation therapy (SBRT). SBRT carries potential risks of radiation induced myelopathy (RIM) and vertebral compression fracture (VCF). Magnetic resonance imaging (MRI) is a sensitive imaging modality that may be able to detect radiation-induced damage in the vertebral body or spinal cord following SBRT. Quantitative MR-based imaging methods may also help to quantify treatment response and help predict subsequent outcomes such as tumor control and VCF risk.

Official Title
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Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases

Conditions
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Spinal Metastases

Intervention / Treatment
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* Device: qMRI with Gadoteridol contrast agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of metastatic cancer with a vertebral body metastasis or contiguous vertebral body metastases for which SBRT is appropriate Age ≥ 18 years of age KPS ≥ 70 Life expectancy of at least 3 months No contraindication to undergoing MR imaging Women of childbearing age must have a negative urine or serum pregnancy test to meet eligibility per Duke Policy Pre-treatment pain score of at least 1/10 based on the numeric pain rating scale (NPRS) Disease located from C1 to S5 Subjects with prior radiation to the involved vertebral body are allowed. Exclusion Criteria: Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia) Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed. Subjects with spinal cord compression; minimally invasive separation surgery to first resect the epidural component is allowed Pregnant or breast-feeding women Allergy to standard IV contrast agents used in MRI Subjects with eGFR <30 30 mL/min2 or on dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quantitative MRI at 4 weeks<br> | Device: qMRI with Gadoteridol contrast agent<br>* quantitative MR: MRI uses a magnet and radio waves to make medical images of the body. Gadoteridol is used as a contrast agent. Quantitative MRI involves the use of software to analyze the acquired images.<br>* Other names: quantitative MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI) |  | baseline, 4 wks | 
| Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI) |  | baseline, 4 wks | 
| Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI |  | baseline, 4 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in numeric pain score as measured by the Numeric Pain Rating Scale | Measured from 0-10 with 0 being no pain and 10 being severe pain | baseline, 4 wks | 
| Change in numeric pain score as measured by the Brief Pain Inventory | Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain | baseline, 4 wks | 
| Change in numeric pain score as measured by the EQ5D Pain Questionnaire | Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain | baseline, 4 wks | 
| Change in opioid use |  | baseline, 4 wks | 
| Change in quality of life as measured by the Pat Sf36 V2 assessment | Pat SF36 V2 is a quality of life survey about physical activity, general health and daily functions measured from excellent/much better/yes, limited a lot/all of the time/not at all, through poor/much worse/no,not limited at all/none of the time/extremely with additional not answered option | baseline, 4 wks | 
| Change in quality of life as measured by the PROMIS assessment | PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much. | baseline, 4 wks | 
| Change in quality of life as measured by the SOSG+ assessment | Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much | baseline, 4 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral compression fracture, Radiation induced myelopathy