Spinal Metastases
Conditions
Keywords
Vertebral compression fracture, Radiation induced myelopathy
Brief summary
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
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.
Interventions
DEVICEqMRI with Gadoteridol contrast agent
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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in numeric pain score as measured by the EQ5D Pain Questionnaire | baseline, 4 wks | Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain |
| Change in quality of life as measured by the Pat Sf36 V2 assessment | baseline, 4 wks | 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 |
| Change in opioid use | baseline, 4 wks | — |
| Change in quality of life as measured by the SOSG+ assessment | baseline, 4 wks | Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much |
| Change in quality of life as measured by the PROMIS assessment | baseline, 4 wks | PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much. |
| Change in numeric pain score as measured by the Numeric Pain Rating Scale | baseline, 4 wks | Measured from 0-10 with 0 being no pain and 10 being severe pain |
| Change in numeric pain score as measured by the Brief Pain Inventory | baseline, 4 wks | Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain |
Countries
United States
Outcome results
None listed