qMRI Assessment After SBRT for Spinal Cancer
Recruiting in Palo Alto (17 mi)
Overseen byScott Floyd, MD PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: MRI incompatibility, Spinal cord compression, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the treatment using qMRI and SBRT for spinal cancer safe for humans?
The studies reviewed focus on the effectiveness and imaging aspects of SBRT and MRI in treating spinal and liver cancers, but they do not provide specific safety data for humans regarding the use of qMRI or related agents like Gadoteridol.
12345How is the treatment using Gadoteridol and qMRI after SBRT for spinal cancer different from other treatments?
This treatment is unique because it combines Gadoteridol, a contrast agent used in MRI scans, with quantitative MRI (qMRI) to assess the effectiveness of stereotactic body radiotherapy (SBRT) for spinal cancer. This approach may help in early detection of treatment response by providing detailed imaging biomarkers, which is not typically available with standard treatments.
13567Eligibility Criteria
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.Inclusion Criteria
No contraindication to undergoing MR imaging
I have had radiation therapy on my spine before.
I am mostly able to care for myself.
+6 more
Exclusion Criteria
Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia)
Pregnant or breast-feeding women
Allergy to standard IV contrast agents used in MRI
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive stereotactic body radiation therapy (SBRT) for spinal metastases
1 week
Imaging Assessment
Quantitative MRI is performed to assess changes in the tumor/vertebral body and adjacent spinal cord
4 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after radiation therapy
4 weeks
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: quantitative MRI at 4 weeksExperimental Treatment1 Intervention
Gadoteridol is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as ProHance for:
- Detection and visualization of lesions and abnormal vascularity in the brain, spine, and liver
🇺🇸 Approved in United States as ProHance for:
- Detection and visualization of lesions and abnormal vascularity in the brain, spine, and liver
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke Cancer CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Early magnetic resonance imaging biomarkers to predict local control after high dose stereotactic body radiotherapy for patients with sarcoma spine metastases. [2018]Recent advances in image guidance and stereotactic body radiotherapy (SBRT) have resulted in unprecedented local control for spinal metastases of all histologies. However, little is known about early imaging biomarkers of local control.
Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases. [2022]In this phase 1/2 study, the authors tested the hypothesis that single-fraction stereotactic body radiotherapy (SBRT) for previously unirradiated spinal metastases is a safe, feasible, and efficacious treatment approach.
Predictive model based on DCE-MRI and clinical features for the evaluation of pain response after stereotactic body radiotherapy in patients with spinal metastases. [2023]To investigate the correlation of conventional MRI, DCE-MRI and clinical features with pain response after stereotactic body radiotherapy (SBRT) in patients with spinal metastases and establish a pain response prediction model.
Hepatic reaction dose for parenchymal changes on Gd-EOB-DTPA-enhanced magnetic resonance images after stereotactic body radiation therapy for hepatocellular carcinoma. [2022]The present study evaluated the threshold dose for hepatic parenchymal changes on gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) images after stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC).
Targeting Accuracy of Image-Guided Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma in Real-Life Clinical Practice: In Vivo Assessment Using Hepatic Parenchymal Changes on Gd-EOB-DTPA-Enhanced Magnetic Resonance Images. [2019]Stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC) has emerged as an alternative treatment option when curative treatment modalities cannot be applied. Although excellent local tumor control has been achieved with SBRT, the targeting accuracy in real-life practice remains poorly understood. We proposed an in vivo assessment of targeting accuracy using hepatic parenchymal changes observed on gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) images and applied this method to investigate the "real-life" targeting accuracy of image-guided SBRT.
Dosimetric analysis of MR-LINAC treatment plans for salvage spine SBRT re-irradiation. [2022]We investigated the feasibility of thoracic spine stereotactic body radiotherapy (SBRT) using the Elekta Unity magnetic resonance-guided linear accelerator (MRL) in patients who received prior radiotherapy. We hypothesized that Monaco treatment plans can improve the gross tumor volume minimum dose (GTVmin) with spinal cord preservation and maintain consistent plan quality during daily adaptation.
Is helical tomotherapy accurate and safe enough for spine stereotactic body radiotherapy? [2021]We assessed the accuracy and safety of spine stereotactic body radiation therapy (SBRT) using helical tomotherapy (HT) via evaluating intrafractional patient movement.