CancerNCT03432936
Prospective Use of Philips iSuite for Interventional Procedures
A study testing MRI guided procedure software evaluation in people with Cancer and Tumor, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- MRI guided procedure software evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients already scheduled for a percutaneous MR guided procedure
Who cannot join
- Pregnant Women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Being tested
- MRI guided procedure software evaluation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI guided procedure software evaluationDevice
MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.
| Study group | Role | What they receive |
|---|---|---|
| MRI guided procedure software evaluation | Experimental | Evaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement. Receives: Device: MRI guided procedure software evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle placement efficiency into target lesion
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.
Measured: Baseline (completion of MRI-guided biopsy and /or ablation procedure)
Secondary outcomes (1)
Software ease of use in targeting lesion for treatment
Evaluate the ease of use of the software for needle placement
Measured: Baseline (completion of MRI-guided biopsy and /or ablation procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
- Investigators
- David A Woodrum, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432936
- Sponsor's protocol ID
- 17-007674
- Status last verified
- Mar 2026
- First submitted
- 2 Jan 2018
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Use of Philips iSuite for Interventional Procedures
- ClinicalTrials.gov ID
- NCT03432936
- Acronym / sponsor ID
- 17-007674
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI guided procedure software evaluation | Experimental | Device: MRI guided procedure software evaluationEvaluate the workflow and effectiveness of the Philips Interventional iSuite software during biopsies and/or ablations versus standard MR imaging in aiding needle placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients already scheduled for a percutaneous MR guided procedure
Key exclusion criteria (1 listed)
- Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI guided procedure software evaluationMRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools. | Device | MRI guided procedure software evaluation |
Primary outcome
Needle placement efficiency into target lesion
Time frame: 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.
1 secondary outcome
Software ease of use in targeting lesion for treatment
Time frame: Baseline (completion of MRI-guided biopsy and /or ablation procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A Woodrum, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI guided procedure software evaluation in people with Cancer and Tumor, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle placement efficiency into target lesion (time frame: Baseline (completion of MRI-guided biopsy and /or ablation procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.