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Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

Primary Purpose

Spinal Metastases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
qMRI with Gadoteridol contrast agent
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Spinal Metastases focused on measuring Vertebral compression fracture, Radiation induced myelopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

quantitative MRI at 4 weeks

Arm Description

Outcomes

Primary Outcome Measures

Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)
Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI

Secondary Outcome Measures

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
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
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
Change in opioid use
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
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.
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

Full Information

First Posted
January 23, 2020
Last Updated
August 14, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04248543
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
Vertebral compression fracture, Radiation induced myelopathy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
quantitative MRI at 4 weeks
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
qMRI with Gadoteridol contrast agent
Other Intervention Name(s)
quantitative MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)
Time Frame
baseline, 4 wks
Title
Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
Time Frame
baseline, 4 wks
Title
Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI
Time Frame
baseline, 4 wks
Secondary Outcome Measure Information:
Title
Change in numeric pain score as measured by the Numeric Pain Rating Scale
Description
Measured from 0-10 with 0 being no pain and 10 being severe pain
Time Frame
baseline, 4 wks
Title
Change in numeric pain score as measured by the Brief Pain Inventory
Description
Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain
Time Frame
baseline, 4 wks
Title
Change in numeric pain score as measured by the EQ5D Pain Questionnaire
Description
Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain
Time Frame
baseline, 4 wks
Title
Change in opioid use
Time Frame
baseline, 4 wks
Title
Change in quality of life as measured by the Pat Sf36 V2 assessment
Description
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
Time Frame
baseline, 4 wks
Title
Change in quality of life as measured by the PROMIS assessment
Description
PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much.
Time Frame
baseline, 4 wks
Title
Change in quality of life as measured by the SOSG+ assessment
Description
Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much
Time Frame
baseline, 4 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor Fryman, BS
Phone
(919) 668-3726
Email
taylor.fryman@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Cahill, RN BNS OCN
Phone
(919) 668-5211
Email
Joan.Cahill@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trey Mullikin, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Fryman, BS
Phone
919-668-3726
Email
Taylor.Fryman@duke.edu
First Name & Middle Initial & Last Name & Degree
Trey Mullikin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

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