Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

Duke University

Status

Completed

Conditions

Spinal Metastases

Treatments

Device: qMRI with Gadoteridol contrast agent

Study type

Interventional

Funder types

Other

Identifiers

NCT04248543

Pro00103960

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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