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Completed

NCT Number: NCT04248543

Quantitative MRI for Functional Assessment Following SBRT 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.

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Key information

Conditions

Spinal Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: quantitative MRI

Primary outcomes

  1. Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)

    Time frame: baseline, 4 wks

  2. Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)

    Time frame: baseline, 4 wks

  3. Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI

    Time frame: baseline, 4 wks

Secondary outcomes

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

    Time frame: baseline, 4 wks

    Measured from 0-10 with 0 being no pain and 10 being severe pain

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

    Time frame: baseline, 4 wks

    Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain

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

    Time frame: baseline, 4 wks

    Measured from 0-10 with 0 being no pain and 10 being worst imaginable pain

  4. Change in opioid use

    Time frame: baseline, 4 wks

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

    Time frame: baseline, 4 wks

    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

  6. Change in quality of life as measured by the PROMIS assessment

    Time frame: baseline, 4 wks

    PROMIS categories include physical function, anxiety, depression, fatigue, sleep and pain ranging from never/not at all through always/very much.

  7. Change in quality of life as measured by the SOSG+ assessment

    Time frame: baseline, 4 wks

    Questionnaire about physical function, neurological function and pain ranging from never/not at all through always/very much

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2020
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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