Cancer, Tumor
Conditions
Brief summary
This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.
Detailed description
The purpose of this study is to evaluate Philips Interventional iSuite software used for MRI guided procedures in the MRI suite. The real-time MRI Imaging software will be used during an MRI procedure to take continuous pictures. The Philips Interventional iSuite software package has not received FDA 510(k) clearance. The Investigator will be evaluating and publishing on the use of this software as a clinical aid in performing interventional procedures within the MR suite. The primary evaluation will be weighted toward enhanced facilitation of ablation procedures. However, the software will not replace standard MR imaging for final confirmation of needle tip position and ablation margins.
Interventions
MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.
Sponsors
Mayo Clinic
Philips Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients already scheduled for a percutaneous MR guided procedure
Exclusion criteria
* Pregnant Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needle placement efficiency into target lesion | Baseline (completion of MRI-guided biopsy and /or ablation procedure) | Needle placement efficiency record time to final needle position, and compare overall similarity of use with current CT guided intervention during the interventional procedure in order to determine how the iSuite may facilitate intervention with the MRI environment. Each operator will fill out a short questionnaire after each intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Software ease of use in targeting lesion for treatment | Baseline (completion of MRI-guided biopsy and /or ablation procedure) | Evaluate the ease of use of the software for needle placement |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid A Woodrum, M.D., Ph.D.
Mayo Clinic
Outcome results
None listed