Evaluate the Role of Real-time Imaging in Needle PlacementNCT01644578
Prospective Use of Real-time MRI
A study testing Real-time imaging for MRI-guided procedures in people with Evaluate the Role of Real-time Imaging in Needle Placement and Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Evaluate the Role of Real-time Imaging in Needle Placement, Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging
- What is being tested?
- Real-time imaging for MRI-guided procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 scheduled for a percutaneous MR guided procedure
Who cannot join
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Minnesota
Rochester, Minnesota, 55905
About this study
This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.
- Conditions
- Evaluate the Role of Real-time Imaging in Needle Placement, Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging
- Being tested
- Real-time imaging for MRI-guided procedures
- Keywords
- MRI, real-time imaging, workflow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time imaging for MRI-guided proceduresProcedure or surgery
Real-time imaging for improvement of workflow in MRI-guided procedures
| Study group | Role | What they receive |
|---|---|---|
| Real-time imaging for MRI-guided procedures | Other | Real-time imaging for improvement of workflow in MRI-guided procedures Receives: Procedure: Real-time imaging for MRI-guided procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the time required for each step for needle placement
Measured: Intra-procedure
Secondary outcomes (1)
Determine ease of use of the software
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startOct 2012
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Role of Real-time Imaging in Needle PlacementStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Woodrum, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644578
- Sponsor's protocol ID
- 09-005887
- Status last verified
- Jun 2019
- First submitted
- 17 Jul 2012
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Use of Real-time MRI
- ClinicalTrials.gov ID
- NCT01644578
- Acronym / sponsor ID
- 09-005887
- Conditions
- Evaluate the Role of Real-time Imaging in Needle Placement, Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging
- Keywords
- MRI, real-time imaging, workflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 19 Jul 2012 (estimated)
- 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 a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-time imaging for MRI-guided procedures | Other | Procedure: Real-time imaging for MRI-guided proceduresReal-time imaging for improvement of workflow in MRI-guided procedures |
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 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 |
|---|---|---|
| Real-time imaging for MRI-guided proceduresReal-time imaging for improvement of workflow in MRI-guided procedures | Procedure or surgery | Real-time imaging for MRI-guided procedures |
Primary outcome
Determine the time required for each step for needle placement
Time frame: Intra-procedure
1 secondary outcome
Determine ease of use of the software
Time frame: Intra-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
David Woodrum, MD, PhD 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 Real-time imaging for MRI-guided procedures in people with Evaluate the Role of Real-time Imaging in Needle Placement and Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging, 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: finished, as of the sponsor's last update on 10 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the time required for each step for needle placement (time frame: Intra-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 10 Mar 2023.