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Diagnostic Imaging Agent
qMRI Assessment After SBRT for Spinal Cancer
N/A
Recruiting
Led By Scott Floyd, MD PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with prior radiation to the involved vertebral body are allowed.
KPS ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 wks
Awards & highlights
Study Summary
This trial will test if qMRI can show changes in tumors and the spine after SBRT, a type of radiation therapy, for people with metastatic spine disease.
Who is the study for?
This trial is for adults with a pain score of at least 1/10 from spinal cancer metastases, who are expected to live more than 3 months and can undergo MRI scans. It's not for those with non-MRI compatible implants, severe claustrophobia, prior vertebral interventions causing artifacts (except some surgeries), pregnant or breastfeeding women, people allergic to MRI contrast agents, or those with very poor kidney function.Check my eligibility
What is being tested?
The study tests if qMRI using Gadoteridol contrast can measure changes in tumors and the spinal cord after SBRT treatment for spine metastases. The goal is to see if this imaging technique provides an objective way to assess how well the therapy works on painful spinal tumors.See study design
What are the potential side effects?
Potential side effects may include reactions to the Gadoteridol contrast agent used during qMRI such as mild discomforts like headache or nausea; rare but serious risks include allergic reactions and kidney problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had radiation therapy on my spine before.
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I am mostly able to care for myself.
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I am 18 years old or older.
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My cancer has spread to the bones in my spine and is suitable for targeted radiation therapy.
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My condition affects my spine from the neck down to the lower back.
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I experience pain from my condition, scoring at least 1 out of 10.
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I am a woman of childbearing age and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 wks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 wks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diffusion Tensor Imaging
Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
Magnetic Resonance Imaging
Secondary outcome measures
Change in numeric pain score as measured by the Brief Pain Inventory
Change in numeric pain score as measured by the EQ5D Pain Questionnaire
Change in numeric pain score as measured by the Numeric Pain Rating Scale
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: quantitative MRI at 4 weeksExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,355 Previous Clinical Trials
3,409,021 Total Patients Enrolled
Scott Floyd, MD PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
Trey Mullikin, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy on my spine before.I am mostly able to care for myself.I am 18 years old or older.You are expected to live for at least 3 more months.My cancer has spread to the bones in my spine and is suitable for targeted radiation therapy.My condition affects my spine from the neck down to the lower back.I had minor surgery to relieve spinal cord compression.My kidney function is very low or I am on dialysis.I experience pain from my condition, scoring at least 1 out of 10.I have had surgery on my spine that did not involve adding instruments to the affected area.I am a woman of childbearing age and have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: quantitative MRI at 4 weeks
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the scientific investigation seeking additional participants?
"As referenced on clinicaltrials.gov, this trial is actively recruiting patients for participation. The listing was initially posted on December 22nd 2020 and has been amended as recently as October 11th 2022."
Answered by AI
What is the current enrollment rate of participants in this medical trial?
"Affirmative. Clinicaltrials.gov data indicates that this medical trial is actively recruiting, which began on December 22nd of 2020 and was most recently updated on October 11th 2022. The clinical study requires the enrolment of 20 participants from a single site."
Answered by AI
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