CompletedNot Applicable

Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases

United States25 participantsStarted 2020-12-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline, 4 wks

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

Timeframe: baseline, 4 wks

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

Timeframe: baseline, 4 wks

Trial details

NCT IDNCT04248543

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-02

View on ClinicalTrials.gov More Spinal Metastases trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: baseline, 4 wks

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

Timeframe: baseline, 4 wks

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

Timeframe: baseline, 4 wks