Clinical trial NCT04248543: Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases
Official title: Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Metastases
Keywords: Vertebral compression fracture
Radiation induced myelopathy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)
timeFrame: baseline, 4 wks
measure: Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
timeFrame: baseline, 4 wks
measure: Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI
timeFrame: baseline, 4 wks
Secondary outcomes:
measure: Change in numeric pain score as measured by the Numeric Pain Rating Scale
timeFrame: baseline, 4 wks
measure: Change in numeric pain score as measured by the Brief Pain Inventory
timeFrame: baseline, 4 wks
measure: Change in numeric pain score as measured by the EQ5D Pain Questionnaire
timeFrame: baseline, 4 wks
measure: Change in opioid use
timeFrame: baseline, 4 wks
measure: Change in quality of life as measured by the Pat Sf36 V2 assessment
timeFrame: baseline, 4 wks
measure: Change in quality of life as measured by the PROMIS assessment
timeFrame: baseline, 4 wks
measure: Change in quality of life as measured by the SOSG+ assessment
timeFrame: baseline, 4 wks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Trey Mullikin, MD
role: PRINCIPAL_INVESTIGATOR
References: