MRI-Guided Ablation Technology Evaluation in Healthy Subjects

Overseen By Desirae Howe-Clayton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new MRI-guided ablation technology to determine if it can make imaging faster or clearer during procedures. It includes both healthy volunteers and patients already scheduled for MRI-guided procedures. The goal is to improve the effectiveness of these procedures. Participants should be either healthy or already scheduled for an MRI-guided procedure. As an unphased study, this trial allows participants to contribute to innovative research that could enhance medical imaging techniques.

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.

What prior data suggests that this MRI-guided ablation is safe?

Research has shown that MRI-guided ablation is generally safe, though some side effects can occur. In studies, about 25% of participants experienced issues such as pain, skin burns, and urinary tract infections. However, serious complications are rare. One study found no side effects in 11 different cases, indicating that these problems do not always occur.

Overall, while potential risks like tissue damage exist, the treatment is usually well-tolerated. As this is an early-stage study, the technology continues to be improved for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided ablation because it offers a precise, non-invasive way to target tissues, potentially improving outcomes for patients needing such interventions. Unlike traditional surgical options, this technique uses MRI to guide the ablation process, allowing for real-time visualization and accuracy. This could mean less damage to surrounding healthy tissues and a quicker recovery time for patients. Overall, MRI-guided ablation is a promising development in medical imaging and treatment precision.

What evidence suggests that MRI Guided Ablation is effective for improving iMRI procedures?

Research has shown that MRI-guided ablation could be a highly effective treatment. Studies have found it to be more effective and safer than other methods, such as ultrasound, particularly for liver cancer treatment. This technique uses MRI to precisely target the treatment area, potentially leading to better outcomes. One study found that MRI-guided ablation has an 80.7% likelihood of being the most effective option compared to similar treatments. Although the results are promising, further research is necessary to fully understand its long-term effects and safety.

In this trial, healthy volunteers will undergo imaging to optimize image parameters, while patients will receive MRI-guided procedures to evaluate potential benefits during MR-guided interventions. ^{6 7 8 9 10}

Who Is on the Research Team?

Aiming Lu, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy adults who are already scheduled for an MRI-guided procedure. It's open to both men and women over the age of 18. Pregnant women cannot participate.

Inclusion Criteria

I am either male or female.

Healthy volunteers or patients already scheduled for a MR-guided procedure.

Exclusion Criteria

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Optimization

Imaging of healthy volunteers to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients

4-8 weeks

MRI-Guided Procedures

Evaluation of advanced MR imaging methods during MRI-guided interventions to assess potential benefits

3 years

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI Guided Ablation

Trial Overview The study is testing a new non-significant risk operation MRI technology during procedures guided by MRI, aiming to see if it can speed up data collection or improve image quality.

How Is the Trial Designed?

Group I: Patients receiving MRI-guided procedures Experimental Treatment 1 Intervention

As described in the study protocol this imaging would be performed to evaluate a given sequence for potential benefit during MR-guided interventions.

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

Imaging of healthy volunteers would performed to optimize image parameters (contrast, SNR) prior to clinical imaging of actual patients receiving treatment.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study involving 64 patients with 100 liver tumors, MR-guided radiofrequency ablation achieved a technical success rate of 97.7%, demonstrating its effectiveness in treating hepatic malignancies.

The procedure allowed for complete tumor coagulation in 92.9% of cases, with most tumors (89.1%) requiring only a single session, indicating both safety and efficiency in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided radiofrequency ablation in a 0.2-T open MR system: technical success and technique effectiveness in 100 liver tumors. Clasen, S., Boss, A., Schmidt, D., et al.[2007]

Magnetic resonance-guided freehand radiofrequency ablation (RFA) is feasible and safe for treating liver malignancies, with a successful procedure rate in all 57 patients studied, and no major complications reported.

Using a liver-specific contrast agent significantly improved lesion visibility, which enhanced targeting during the RFA procedure, making it simpler and quicker compared to previous methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided freehand radiofrequency ablation of malignant liver lesions: a new simplified and time-efficient approach using an interactive open magnetic resonance scan platform and hepatocyte-specific contrast agent. Fischbach, F., Lohfink, K., Gaffke, G., et al.[2013]

Magnetic resonance-guided laser thermal ablation (LTA) is a safe and feasible treatment for liver tumors, showing a significant reduction in viable tumor tissue, with an average of 50.7% of the tumor ablated per treatment.

Patients undergoing MR-guided LTA had a mean overall survival of 14.8 months, which is favorable compared to untreated patients, particularly for those with hepatocellular carcinoma (HCC), indicating its potential effectiveness in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided laser thermal ablation of primary and secondary liver tumours. Dick, EA., Joarder, R., de Jode, M., et al.[2019]

Magnetic resonance-guided radiofrequency ablation (RFA) of liver tumors was successfully performed on 10 patients, demonstrating technical feasibility and safety, with no major complications reported.

Local tumor control was achieved in 9 out of 10 patients, indicating that MR-guided RFA can be an effective treatment option for hepatic malignancies, especially in challenging locations where traditional methods may not be suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided radiofrequency ablation of hepatic malignancies at 1.5 T: initial results. Mahnken, AH., Buecker, A., Spuentrup, E., et al.[2004]

Monitoring radio-frequency (RF) ablation using the proton-frequency-shift (PFS) technique in a 0.5-T magnetic resonance imager is feasible and provides accurate assessments of coagulation size in both porcine muscle and liver, with 22 out of 24 and 9 out of 12 lesions detected, respectively.

The PFS technique significantly outperformed the T1-weighted imaging method, which only identified a few lesions and often underestimated their sizes, highlighting the importance of using PFS for better accuracy in monitoring RF ablation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radio-frequency-induced thermoablation: monitoring with T1-weighted and proton-frequency-shift MR imaging in an interventional 0.5-T environment. Steiner, P., Botnar, R., Dubno, B., et al.[2007]

The new MRI-compatible irrigated laser microcatheter system demonstrated effective thermal ablation of liver metastases in 28 patients, achieving successful treatment with a mean coagulation volume of 23.9 mL.

The procedure is minimally invasive and well tolerated, allowing for precise catheter placement and real-time monitoring, which enhances safety and efficacy during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser-induced thermotherapy (LITT) of liver metastases: MR-guided percutaneous insertion of an MRI-compatible irrigated microcatheter system using a closed high-field unit. Puls, R., Stroszczynski, C., Gaffke, G., et al.[2014]

In a study involving 15 patients with 18 hepatic malignancies, MR-guided microwave ablation achieved technical success and effectiveness in all treated lesions, demonstrating its feasibility as a one-session treatment.

The procedure was safe, with only two minor complications reported, and it allowed for effective monitoring and planning without the need for contrast enhancement, making it a promising option for treating liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided microwave ablation in hepatic tumours: initial results in clinical routine. Hoffmann, R., Rempp, H., Keßler, DE., et al.[2021]

The microwave (MW) applicator demonstrated a satisfactory artefact configuration for MR-guided tumor ablation, with a smaller shaft artefact diameter (2.3 mm) compared to the radiofrequency (RF) applicator (8.9 mm), indicating it may be more suitable for precise imaging during procedures.

The MW applicator's artefact appearance was found to be independent of its orientation to the main magnetic field, which could enhance its usability in MR-guided ablation, while the RF applicator showed minimal artefacts when aligned parallel to the magnetic field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro artefact assessment of a new MR-compatible microwave antenna and a standard MR-compatible radiofrequency ablation electrode for tumour ablation. Hoffmann, R., Rempp, H., Eibofner, F., et al.[2020]

In a study involving 110 patients with liver malignancies, MR-guided radiofrequency ablation achieved a high technical success rate of 98.6% and an overall effectiveness rate of 93.4% for treating liver lesions.

The procedure demonstrated a good safety profile, with only 2 major complications (1.3%) and 14 minor complications (8.9%) reported, indicating that it is a safe option for patients with liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided radiofrequency ablation using a wide-bore 1.5-T MR system: clinical results of 213 treated liver lesions. Rempp, H., Waibel, L., Hoffmann, R., et al.[2021]

Citations

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Effect of MRI-Guided Fibrosis Ablation vs Conventional ... The Efficacy of Delayed Enhancement-MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation ... Efficacy Outcomes by Fibrosis Stages: <20% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11678844/

Percutaneous Magnetic Resonance Imaging-Guided Focal ... However, data on long-term outcomes remain limited, emphasizing the need for further studies on MRI-FLA's sustained efficacy and safety. In the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0009926025002442

Network Meta-Analysis of the Efficacy and Safety ... CT/MRI-guided ablation outperforms ultrasound in HCC efficacy and safety. · MRI guidance achieves highest efficacy with 80.7% probability of ...

4. jacc.org jacc.org/doi/10.1016/j.jaccas.2025.104184

Safety, Efficacy, and 2-Year Outcomes of Cardiovascular ... iCMR-guided ablation of CTI-dependent atrial flutter demonstrates a good safety profile and efficacy at 2-year follow-up. Abbreviations and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02529319

Efficacy of Delayed Enhancement MRI-Guided Ablation vs ... This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36775655/

a systematic review and future perspectives The mean occurrence of all AEs in the analyzed material was 24.67%. The most commonly described AEs included pain, skin burns, urinary tract infections and ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2023.2174274

Full article: Adverse events and complications after ... According to available evidence, the overall incidence of serious complications in MRgFUS therapy is relatively low. No AEs/complications were reported in 11 ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH. Below is a list of the potential adverse effects (e.g., complications) associated with the use.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1930043324004448

Complication detection in MRI guided cardiac ablation These destructive energies have the potential to cause unintentional disruption of the atrial wall, myocardial perforation, and collateral injury to the tissues ...

10. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2793452

Effect of MRI-Guided Fibrosis Ablation vs Conventional ... In this randomized clinical trial that included 843 patients with persistent AF, there was no significant difference in atrial arrhythmia recurrence in the MRI ...