Thoracic Spine NeoplasmEarly Phase 1NCT04563806
Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery
A Early Phase 1 study testing Magnetic Resonance Imaging and Therapeutic Conventional Surgery in people with Thoracic Spine Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Spine Neoplasm
- What is being tested?
- Magnetic Resonance Imaging and Therapeutic Conventional Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 19 May 2022
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson
- Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
- All diagnoses are eligible
- Vertebral body site to be treated located from T2 to T12
- Signed informed consent
Who cannot join
- Requires open spinal procedure or a percutaneous procedure without the use of image guidance
- Unable to tolerate general anesthesia and prone position
- Unable to undergo MRI scan of the spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures
This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.
Read the detailed description
PRIMARY OBJECTIVE:
- To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures.
SECONDARY OBJECTIVE:
- To determine the accuracy of the MRI-based image guidance.
OUTLINE:
Patients undergo standard of care spine surgery with MRI-based image guidance.
- Conditions
- Thoracic Spine Neoplasm
- Being tested
- Magnetic Resonance Imaging, Therapeutic Conventional Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI-guided surgery
Therapeutic Conventional SurgeryProcedure or surgery
Undergo spinal surgery
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (MRI-guided surgery) | Experimental | Patients undergo standard of care spine surgery with MRI-based image guidance. Receives: Device: Magnetic Resonance Imaging; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative adverse events
Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start18 Apr 2019
- Primary completion19 May 2022
- Study completion19 May 2022
Why it stopped: Per PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Spine NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Claudio E Tatsui, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563806
- Sponsor's protocol ID
- 2017-0663
- Other IDs
- NCI-2020-03700, 2017-0663
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2020
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures
- ClinicalTrials.gov ID
- NCT04563806
- Acronym / sponsor ID
- 2017-0663
- Conditions
- Thoracic Spine Neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 24 Sep 2020 (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 trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.
Detailed description
PRIMARY OBJECTIVE:
- To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures.
SECONDARY OBJECTIVE:
- To determine the accuracy of the MRI-based image guidance.
OUTLINE:
Patients undergo standard of care spine surgery with MRI-based image guidance.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (MRI-guided surgery) | Experimental | Device: Magnetic Resonance Imaging, Procedure: Therapeutic Conventional SurgeryPatients undergo standard of care spine surgery with MRI-based image guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson
- Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
- All diagnoses are eligible
- Vertebral body site to be treated located from T2 to T12
- Signed informed consent
Key exclusion criteria (3 listed)
- Requires open spinal procedure or a percutaneous procedure without the use of image guidance
- Unable to tolerate general anesthesia and prone position
- Unable to undergo MRI scan of the spine
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI-guided surgery | Device | Device feasibility (MRI-guided surgery) |
| Therapeutic Conventional SurgeryUndergo spinal surgery | Procedure or surgery | Device feasibility (MRI-guided surgery) |
Primary outcome
Incidence of intraoperative adverse events
Time frame: During surgery
Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.
Results and safety
The study was stopped early (reason given: Per PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Claudio E Tatsui principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnetic Resonance Imaging and Therapeutic Conventional Surgery in people with Thoracic Spine Neoplasm, run by M.D. Anderson Cancer Center 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Jul 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per PI). Results are not available in the source record.
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?
Incidence of intraoperative adverse events (time frame: During surgery). 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 11 Jul 2022.