qMRI Assessment After SBRT for Spinal Cancer

Overseen By Joan Cahill, RN BNS OCN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: MRI incompatibility, Spinal cord compression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

25 Participants Needed

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. ^{1 2 3 4 5}

How 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. ^{1 3 5 6 7}

Research Team

Trey Mullikin, MD

Principal Investigator

Duke University

Eligibility 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.

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

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

Treatment Details

Interventions

• Gadoteridol
• qMRI

Trial Overview 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.

Participant Groups

Group I: quantitative MRI at 4 weeks Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

In a study of 9 patients with metastatic sarcoma spine lesions treated with stereotactic body radiotherapy (SBRT), early changes in perfusion metrics from dynamic contrast-enhanced MRI (DCE-MRI) were found to significantly correlate with local control, indicating their potential as early imaging biomarkers.

The mpMRI score demonstrated 100% accuracy in predicting local control at the last follow-up, suggesting that traditional size measurements alone are not sufficient to assess treatment response after SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early magnetic resonance imaging biomarkers to predict local control after high dose stereotactic body radiotherapy for patients with sarcoma spine metastases. Spratt, DE., Arevalo-Perez, J., Leeman, JE., et al.[2018]

In a phase 1/2 study involving 61 patients with spinal metastases, single-fraction stereotactic body radiotherapy (SBRT) demonstrated a high local control rate of 88% and an overall survival rate of 64% over an 18-month follow-up period, indicating its efficacy as a treatment option.

While SBRT was generally safe, with only two patients experiencing significant radiation-related adverse events, the study suggests the need for further research to identify factors that could predict spinal cord toxicity, ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases. Garg, AK., Shiu, AS., Yang, J., et al.[2022]

In a study of 89 patients with spinal metastases who underwent stereotactic body radiotherapy (SBRT), 65.2% experienced a positive pain response after treatment, indicating that SBRT can effectively alleviate pain in many cases.

A predictive model based on clinical and imaging features, including the number of treated lesions and DCE-MRI parameters, showed good performance in forecasting pain response, with a C-index of 0.806, which can aid in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive model based on DCE-MRI and clinical features for the evaluation of pain response after stereotactic body radiotherapy in patients with spinal metastases. Chen, Y., Wang, Q., Zhou, G., et al.[2023]

In a study of 20 patients with hepatocellular carcinoma who underwent stereotactic body radiation therapy (SBRT), the threshold dose for detecting changes in liver tissue on Gd-EOB-DTPA-enhanced MR images was found to be approximately 20 Gy, with a median D50 value of 19.8 Gy.

The study highlights that significant parenchymal changes can be observed 2-4 months after administering a total dose of 45 Gy in three fractions, providing important insights for future research on liver function post-radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic reaction dose for parenchymal changes on Gd-EOB-DTPA-enhanced magnetic resonance images after stereotactic body radiation therapy for hepatocellular carcinoma. Jung, J., Yoon, SM., Cho, B., et al.[2022]

In a study of 29 patients treated with stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC), the median intercenter discrepancy (ICD) in targeting accuracy was found to be 6.81 mm, indicating a notable variation in how accurately the treatment targeted the tumor compared to the surrounding liver tissue.

The study demonstrated that the method of guidance (intrahepatic markers vs. diaphragm guidance) did not significantly affect targeting accuracy, suggesting that improvements in targeting techniques may be necessary to enhance treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jung, J., Kim, H., Yoon, SM., et al.[2019]

The study demonstrated that using the Monaco treatment planning system for thoracic spine SBRT significantly improved the minimum dose to the gross tumor volume (GTVmin) compared to previous Pinnacle plans, while still preserving spinal cord safety.

The adaptive treatment plans generated with the Monaco system maintained consistent quality and safety, particularly with the adapt-to-shape (ATS) workflow, which kept spinal cord dose increases minimal (within 3% of reference plans) while allowing for effective tumor dose escalation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric analysis of MR-LINAC treatment plans for salvage spine SBRT re-irradiation. Han, EY., Yeboa, DN., Briere, TM., et al.[2022]

In a study involving 22 patients with spine lesions, the use of helical tomotherapy (HT) for spine stereotactic body radiation therapy (SBRT) demonstrated minimal intrafractional movement, averaging only 1.8 mm, which did not impact the accuracy of dose delivery to the target or spinal cord.

Patient immobilization techniques, such as using a thermoplastic mask and BodyFIX® system, significantly reduced lateral movement and total displacement during treatment, suggesting that proper immobilization enhances the safety and efficacy of SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is helical tomotherapy accurate and safe enough for spine stereotactic body radiotherapy? Chung, Y., Yoon, HI., Kim, JH., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early magnetic resonance imaging biomarkers to predict local control after high dose stereotactic body radiotherapy for patients with sarcoma spine metastases. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Phase 1/2 trial of single-session stereotactic body radiotherapy for previously unirradiated spinal metastases. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

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]

4. Australia pubmed.ncbi.nlm.nih.gov

Hepatic reaction dose for parenchymal changes on Gd-EOB-DTPA-enhanced magnetic resonance images after stereotactic body radiation therapy for hepatocellular carcinoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Dosimetric analysis of MR-LINAC treatment plans for salvage spine SBRT re-irradiation. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Is helical tomotherapy accurate and safe enough for spine stereotactic body radiotherapy? [2021]