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

Trial Summary

What is the purpose of this trial?

The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.

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 data supports the effectiveness of the treatment MRI Guided Ablation?

Research on MRI-guided ablation techniques, like radiofrequency and microwave ablation, shows they are effective in treating liver tumors by successfully targeting and reducing tumor size. These studies indicate that MRI guidance helps in precisely targeting the tumors, making the treatment both feasible and safe. ^{1 2 3 4 5}

Is MRI-guided ablation generally safe for humans?

Research on MRI-guided ablation, including microwave, radiofrequency, and laser methods, shows it is generally safe for treating liver tumors, with studies focusing on patient safety and technical success. ^{1 2 3 6 7}

How is MRI-guided ablation different from other treatments?

MRI-guided ablation is unique because it uses magnetic resonance imaging (MRI) to precisely guide the ablation process, allowing for real-time visualization and targeting of tissues. This approach can be more accurate and safer compared to traditional methods that do not use MRI guidance. ^{2 4 5 8 9}

Research Team

Aiming Lu, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

I am 18 years old or older.

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

Exclusion Criteria

I am 18 years old or older.

You are currently pregnant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

MR-guided laser thermal ablation of primary and secondary liver tumours. [2019]

2. United States 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. [2007]

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

MR-guided microwave ablation in hepatic tumours: initial results in clinical routine. [2021]

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

MR-guided radiofrequency ablation of hepatic malignancies at 1.5 T: initial results. [2004]

5. United States 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. [2013]

6. United States 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. [2014]

7. Germany 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. [2021]

8. United States 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. [2007]

9. Germany 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. [2020]