Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Metastases
• Intervention / Treatment: Device: qMRI with Gadoteridol contrast agent

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taylor Fryman, BS; Phone Number: (919) 668-3726; Email: taylor.fryman@duke.edu
• Study Contact Backup: Name: Joan Cahill, RN BNS OCN; Phone Number: (919) 668-5211; Email: Joan.Cahill@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Center
      • Contact: Taylor Fryman, BS; Phone Number: 919-668-3726; Email: Taylor.Fryman@duke.edu
      • Principal Investigator: Trey Mullikin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quantitative MRI at 4 weeks	Device: 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.; Other Names: quantitative MRI

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in numeric pain score as measured by the Numeric Pain Rating Scale	Measured from 0-10 with 0 being no pain and 10 being severe pain	baseline, 4 wks
Change in numeric pain score as measured by the Brief Pain Inventory	Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain	baseline, 4 wks
Change in numeric pain score as measured by the EQ5D Pain Questionnaire	Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain	baseline, 4 wks
Change in opioid use		baseline, 4 wks
Change in quality of life as measured by the Pat Sf36 V2 assessment	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	baseline, 4 wks
Change in quality of life as measured by the PROMIS assessment	PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much.	baseline, 4 wks
Change in quality of life as measured by the SOSG+ assessment	Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much	baseline, 4 wks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Trey Mullikin, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Vertebral compression fracture; Radiation induced myelopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: Pro00103960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes