Augmented reality guidance for MRI liver needle placement.
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
This research will try an augmented-reality needle guidance system to help adults having MRI-guided liver biopsies or tumor ablations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07120906 on ClinicalTrials.gov |
What this trial studies
The study will test the LUMENA MRI-compatible needle guidance system, which overlays an augmented-reality display to help the operator track the needle path during liver biopsy or ablation. The device does not change the clinical procedure itself but provides real-time visualization while the procedure is done under MRI (or standard imaging guidance). Adults already scheduled for a clinically indicated MRI-guided liver biopsy or ablation are invited to participate and will have a single study visit coinciding with their procedure. Procedures last about 60 minutes for biopsy and up to 4 hours for ablation, and participants remain in the study until the procedure is completed.
Who should consider this trial
Good fit: Adults aged 18–90 referred to Interventional Radiology for image-guided liver biopsy or ablation who can provide informed consent and fit in the MRI scanner are ideal candidates.
Not a fit: Patients with MR-unsafe implants, those who do not fit within the 70 cm MR bore, or those unable to give informed consent are unlikely to benefit or be eligible for participation.
Why it matters
Potential benefit: If successful, the system could improve needle targeting accuracy and may reduce procedure time or complications for patients undergoing MRI-guided liver interventions.
How similar studies have performed: Similar augmented-reality and image-guidance systems have shown feasibility in small studies, but MRI-compatible AR guidance for liver interventions remains relatively novel and less widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, ages 18-90 years * Patient referred to Interventional Radiology for image-guided liver needle placement for ablation/biopsy. Exclusion Criteria: * Patients who are unable to give informed consent themselves or through their parents. * Patients that do not fit into MR scanner (70 cm bore) with room for needle placement. * Contraindications to MRI such as MR-unsafe implants.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: David A. Woodrum, MD, PhD — Mayo Clinic
- Study coordinator: Desirae Howe-Clayton
- Email: Howe.Desirae@mayo.edu
- Phone: 507-255-0111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.