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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of MRI, called quantitative MRI (qMRI), can measure changes in spinal tumors and the spinal cord after stereotactic body radiation therapy (SBRT). The aim is to determine if this imaging can track the effectiveness of treatment for individuals with painful cancer that has spread to the spine. The trial uses a contrast agent, Gadoteridol (also known as ProHance or Gd-HP-DO3A), during the MRI. It seeks participants with confirmed spinal cancer treatable with SBRT who experience pain from it. Participants must be able to undergo MRI scans and should not have undergone certain spinal procedures. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future cancer treatments.

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.

What prior data suggests that qMRI is safe for assessing changes after SBRT?

Research has shown that gadoteridol, a substance used in MRI scans to enhance image clarity, is generally safe. In studies involving over 6,000 patients, no serious side effects occurred. Minor side effects were very rare, occurring in less than 1% of cases, indicating that most people tolerate gadoteridol well.

Regarding qMRI, this imaging technique does not use any drugs, so it typically does not cause side effects. Research has found that qMRI effectively tracks changes in the spine after treatments like radiation therapy.

Overall, both gadoteridol and qMRI appear safe for imaging the spine. For those considering participation in a study using these methods, current research suggests the risks are low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using qMRI after SBRT for spinal cancer because it offers a new way to assess treatment effectiveness. Unlike standard imaging techniques, which might not detect subtle changes in tissue, qMRI provides a detailed quantitative analysis of changes in the tumor and surrounding tissues. This allows for a more precise evaluation of how well the SBRT is working, potentially leading to quicker and more informed treatment decisions. Additionally, the use of gadoteridol as a contrast agent in qMRI enhances the visibility of the cancerous and healthy tissues, which can improve the accuracy of the assessments.

What evidence suggests that qMRI is effective for assessing changes after SBRT for spinal cancer?

Studies have shown that gadoteridol, a type of contrast dye, enhances MRI image quality and aids in diagnosing spinal diseases. Many patients have used it safely, resulting in clear images that assist doctors in identifying spine issues. Research indicates that qMRI (quantitative MRI) provides valuable information about the spinal cord's structure, making it useful for evaluating spinal conditions. In this trial, participants will undergo qMRI four weeks after SBRT to assess changes in spinal tumors and nearby areas. qMRI can also help predict the effectiveness of treatments like stereotactic body radiation therapy (SBRT) for cancer that has spread to the spine. Together, these tools offer a clearer picture of changes in spinal tumors and surrounding areas after treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Trey Mullikin, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

Citations

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MR Contrast Media in Neuroimaging: A Critical Review of the ... Clinical safety and efficacy of gadoteridol: a study in 411 patients with suspected intracranial and spinal disease. Radiology 1991;181:701-709 [DOI] [PubMed] [ ...

2. braccomr.com braccomr.com/prohance-mr/

ProHance - BraccoMR ProHance® is the only GBCA with the option for a cumulative dose up to 3 times standard 0.1 mmol/kg dose in adult patients. Learn more today.

3. sciencedirect.com sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/gadoteridol

Gadoteridol - an overview | ScienceDirect Topics Gadoteridol is defined as a gadolinium-based contrast agent used in magnetic resonance imaging (MRI) to enhance image quality and diagnostic effectiveness. It ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf

ProHance (Gadoteridol) Injection, 279.3 mg/mL ProHance was evaluated in two blinded read trials in a total of 133 adults who had an indication for head and neck extracranial or extraspinal magnetic ...

5. firstwordhealthtech.com firstwordhealthtech.com/story/4908931

Artificial intelligence software confirms the results of a large scale ... The purpose of this study was to use AI to determine the effectiveness of standard concentration ProHance (0.5mmol/ml) compared to double concentration Gadavist ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/020131s027lbl.pdf

ProHance® (Gadoteridol) Injection, 279.3 mg/mL WARNING The results of the non-contrast and gadoteridol. MRI scans were compared. In this database, approximately 75-82% of the scans were enhanced. 45-48% of the scans ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK23123/

Gadoteridol : Gd-HP-DO3A - NCBI - NIH Runge and Parker (29) reported a worldwide clinical safety assessment of gadoteridol in 1997 that indicated a 6.6% incidence rate of total ...

8. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/gadoteridol

Gadoteridol - an overview Gadoteridol is defined as a macrocyclic gadolinium-based contrast agent (GBCA) used in neuroimaging, associated with a low risk of nephrogenic systemic fibrosis ...

9. rxlist.com rxlist.com/prohance-drug.htm

ProHance (Gadoteridol Injection Solution): Side Effects, ... Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ...