Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

NCT ID: NCT04248543

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2025-07-02

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.

Conditions

Spinal Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

quantitative MRI at 4 weeks

Group Type: EXPERIMENTAL

qMRI with Gadoteridol contrast agent

Intervention Type: DEVICE

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.

Interventions

qMRI 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.

Intervention Type: DEVICE

Other Intervention Names

quantitative MRI

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trey Mullikin, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00103960

Identifier Type: -

Identifier Source: org_study_id