MRI-Guided SBRT for Liver Metastases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to determine the safest dose of a specialized radiation treatment called MRI-guided Stereotactic Body Radiation Therapy (SBRT) for individuals with cancer that has spread to the liver or bowel. The trial focuses on using advanced imaging to deliver precise radiation doses. Suitable candidates have confirmed or suspected cancer in the liver that can be treated with this radiation method and no active brain metastases. Participants will engage in the trial for up to 12 months. As an unphased trial, this study allows participants to contribute to cutting-edge research in radiation therapy.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What prior data suggests that MRI-guided SBRT is safe for treating bowel and liver metastases?
Research has shown that MRI-guided Stereotactic Body Radiation Therapy (SBRT) is generally well-tolerated for treating various tumors. One study found that even at higher doses, SBRT achieved a 96% success rate over three years, indicating long-term effectiveness.
Further research suggests that using MRI during SBRT enhances the precision of radiation targeting, making the treatment more accurate and potentially safer. Another study confirmed that MRI-guided SBRT is practical, safe, and effective, even for challenging-to-reach tumors.
The current trial aims to determine the safest maximum dose for treating cancer that has spread to the liver. Previous studies provide reassurance, as they already support the safety of this treatment for other conditions.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new way to treat liver metastases using SBRT (Stereotactic Body Radiation Therapy) with real-time MRI guidance. Unlike traditional radiation therapies, this method allows for dose escalation, meaning higher, more precise doses can be delivered directly to the tumor while minimizing exposure to healthy tissue. The use of adaptive planning means the treatment can be adjusted on the spot based on real-time images, potentially improving effectiveness and reducing side effects. This approach could offer a more targeted and efficient treatment option for patients with liver metastases.
What evidence suggests that MRI-guided SBRT is effective for treating bowel and liver metastases?
Research has shown that MRI-guided Stereotactic Body Radiation Therapy (SBRT) effectively treats tumors in the abdomen and pelvis, including those that have spread to the liver. In this trial, participants will receive MRI-guided SBRT with dose escalation, aiming for a maximum dose of 80 Gy. MRI guidance allows for more precise radiation targeting, delivering a higher dose to the tumor while protecting nearby organs. This precision can improve outcomes for patients with metastatic tumors. Some studies have found improved survival rates for patients with certain types of these tumors treated with this method. Early results suggest that increasing the radiation dose might enhance outcomes without adding side effects. Overall, this treatment shows promise for safely managing challenging cases of tumor spread.23678
Who Is on the Research Team?
Michael Bassetti, MD, PhD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for adults with certain types of cancer that has spread to the liver. They must be able to have MRI scans, not have brain metastases or other serious health issues, and their organs must function well. Women who can get pregnant need a negative pregnancy test and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MRI-guided SBRT treatment in 5 fractions with adaptive planning, maximum dose 80 Gy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of dose limiting toxicity
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- SBRT
Trial Overview
The trial tests how much radiation from Stereotactic Body Radiation Therapy (SBRT) guided by MRI can be safely given to treat liver metastases. Participants will receive this treatment over up to 12 months, aiming to find the highest dose they can tolerate without severe side effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment on MRI Linac with SBRT in 5 fractions with adaptive planning, maximum dose 80 Gy Dose Escalation Bowel Pathway, V34 \< 0.5cc Dose Escalation Liver Pathway, 700 cc \< 16 Gy
SBRT is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Bone metastases
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Citations
Clinical outcomes of stereotactic magnetic resonance image ...
We report the clinical outcomes of stereotactic MRI‐guided adaptive radiotherapy (SMART) for primary and metastatic tumors in the abdomen and pelvis.
Long-term outcomes of Stereotactic MRI-guided adaptive ...
Long-term outcomes of Stereotactic MRI-guided adaptive radiotherapy (SMART) for prostate cancer: Results from a real world large patient cohort.
Stereotactic Body Radiation Therapy: A Radiosurgery ...
Dose escalation has improved biochemical but not metastasis-free survival outcomes in CF-RT. Its use in SBRT has also been explored. Multiple ...
Structure-specific rigid dose accumulation dosimetric ...
MRLs enable safe dose escalation to targets that are nearby critical radiosensitive OAR by utilizing stereotactic MR-guided adaptive radiation ...
Multi-Institutional Outcomes of Stereotactic
Purpose: Randomized data show a survival benefit of stereotactic ablative body radiation therapy in selected patients with oligometastases (OM) ...
Analysis of standard vs dose-escalated stereotactic body ...
In a Phase II trial, localized SBRT (36.25 Gy/5 every other day) yielded promising outcomes. A 36-month follow-up showed a 96% 3-year bPFS rate, ...
Stereotactic Magnetic Resonance Guided Adaptive ...
This is the first prospective study to demonstrate that MR guided single-fraction SBRT is feasible, safe, and effective for not only tumors in the peripheral ...
OAR-Based, Dose Escalated SBRT With Real Time ...
The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided Stereotactic Body Radiation Therapy (SBRT) ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.