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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
KPS ≥ 70
Age ≥ 18 years of age
Must not have
Subjects with eGFR <30 30 mL/min2 or on dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 wks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is very low or I am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 wks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 wks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
2,455 Previous Clinical Trials
2,971,532 Total Patients Enrolled
Scott Floyd, MD PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
Trey Mullikin, MDPrincipal InvestigatorDuke University

Media Library

Gadoteridol (Diagnostic Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04248543 — N/A
Spinal Metastases Research Study Groups: quantitative MRI at 4 weeks
Spinal Metastases Clinical Trial 2023: Gadoteridol Highlights & Side Effects. Trial Name: NCT04248543 — N/A
Gadoteridol (Diagnostic Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248543 — N/A
~0 spots leftby Dec 2024
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