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

  • End date
    Mar 20, 2024
  • participants needed
  • sponsor
    Duke University
Updated on 20 October 2022
serum pregnancy test
stereotactic body radiation therapy
spinal cord
spinal disease


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.


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.

Condition Spinal Metastases
Treatment qMRI with Gadoteridol contrast agent
Clinical Study IdentifierNCT04248543
SponsorDuke University
Last Modified on20 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note