Spinal MetastasesNCT04248543
Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases
A study testing qMRI with Gadoteridol contrast agent in people with Spinal Metastases, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- qMRI with Gadoteridol contrast agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Metastases
- Being tested
- qMRI with Gadoteridol contrast agent
- Keywords
- Vertebral compression fracture, Radiation induced myelopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qMRI with Gadoteridol contrast agentDevice
Also called quantitative MRI
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.
| Study group | Role | What they receive |
|---|---|---|
| quantitative MRI at 4 weeks | Experimental | Not described Receives: Device: qMRI with Gadoteridol contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)
Measured: baseline, 4 wks
Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
Measured: baseline, 4 wks
Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI
Measured: baseline, 4 wks
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: baseline, 4 wks
Change in opioid use
Measured: 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
Measured: 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.
Measured: 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
Measured: baseline, 4 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start22 Dec 2020
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trey Mullikin, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248543
- Sponsor's protocol ID
- Pro00103960
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2020
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases
- ClinicalTrials.gov ID
- NCT04248543
- Acronym / sponsor ID
- Pro00103960
- Conditions
- Spinal Metastases
- Keywords
- Vertebral compression fracture, Radiation induced myelopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quantitative MRI at 4 weeks | Experimental | Device: qMRI with Gadoteridol contrast agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qMRI with Gadoteridol contrast agentAlso: quantitative MRIquantitative 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. | Device | quantitative MRI at 4 weeks |
Primary outcome
Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)
Time frame: baseline, 4 wks
Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
Time frame: baseline, 4 wks
Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI
Time frame: baseline, 4 wks
7 secondary outcomes
Change in numeric pain score as measured by the Numeric Pain Rating Scale
Time frame: baseline, 4 wks
Change in numeric pain score as measured by the Brief Pain Inventory
Time frame: baseline, 4 wks
Change in numeric pain score as measured by the EQ5D Pain Questionnaire
Time frame: baseline, 4 wks
Change in opioid use
Time frame: baseline, 4 wks
Change in quality of life as measured by the Pat Sf36 V2 assessment
Time frame: baseline, 4 wks
Change in quality of life as measured by the PROMIS assessment
Time frame: baseline, 4 wks
Change in quality of life as measured by the SOSG+ assessment
Time frame: baseline, 4 wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trey Mullikin, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qMRI with Gadoteridol contrast agent in people with Spinal Metastases, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI) (time frame: baseline, 4 wks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.