Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

NCT04248543 | Completed FDA Device

• 1 other identifier: Pro00103960
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Metastases

Keywords

Vertebral compression fracture; Radiation induced myelopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in numeric pain score as measured by the Numeric Pain Rating Scale

  baseline, 4 wks

• Change in numeric pain score as measured by the Brief Pain Inventory

  baseline, 4 wks

• Change in numeric pain score as measured by the EQ5D Pain Questionnaire

  baseline, 4 wks

• Change in opioid use

  baseline, 4 wks

• Change in quality of life as measured by the Pat Sf36 V2 assessment

  baseline, 4 wks

Study Arms (1)

quantitative MRI at 4 weeks

EXPERIMENTAL

Device: qMRI with Gadoteridol contrast agent

Interventions

qMRI with Gadoteridol contrast agent 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.

Also known as: quantitative MRI

quantitative MRI at 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Trey Mullikin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: December 22, 2020
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)