Spinal TumorNCT02613390
Safety Evaluation of Intra-Operative MRI-Based Guidance for Laser Ablation of Epidural Metastasis
A study testing Magnetic Resonance Imaging (MRI) and Questionnaires in people with Spinal Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2015to 17 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age =/> 18 years old.
- Must have epidural metastasis to be treated with MRI-guided laser ablation.
- Vertebral body site to be treated is located from C3 to L5.
- 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 of the spine.
- Pregnant female.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study to Evaluate Safety of Intraoperative MRI-Based Image Guidance for Laser Ablation of Epidural Metastasis
The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine.
Read the detailed description
Study Visits:
If you agree to take part in this study, before your surgery:
- You will have a physical exam.
- You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes).
- You will complete questionnaires about pain and other symptoms that should take about 10-15 minutes.
- You will sign a separate consent for your spinal surgery that explains the risks.
During the Surgery:
You will be positioned lying face down on your stomach during surgery. While you are under anesthesia, an MRI will be used to take images of your spine. This is an intraoperative MRI, meaning that it is performed in a special magnet located inside a specifically designed operating room. These images will be loaded into a computer navigation program and will be used to help the doctor perform surgery.
Markers will also be attached to the skin of your back. These markers are used together with the navigation program and MRI images to record the location of where on your spine the doctor should cut. This recording will be compared to the MRI images.
Your doctor will check the accuracy of this recording in 2 ways:
- Placing the tip of the navigation probe on your skin and comparing it with the computer calculation in the computer navigation program. This is a standard navigation probe commonly used in spinal surgeries.
- Inserting the navigation probe through a small cut on your skin along the surgical area and taking an x-ray image of its location.
If there is a difference in the result of these 2 measurements, your doctor will use the result of the first step to check the accuracy of the MRI image.
If there is more than 2 millimeter difference between the visual inspection position and the computer model position, your doctor may decide to do one of the following steps:
- Restart the recording process by getting a new MRI image
- Use only the x-ray images to complete the procedure
- Stop the surgery
On the Day After Surgery:
- You will have a physical exam.
- You will have a neurological exam.
- You will complete the same questionnaires as before.
Follow-Up Visits:
The research staff will call you 3 weeks after surgery to ask about your recovery and you will be asked to answer the same questionnaires as before.
You will return for a follow-up visit after surgery:
- You will have a physical exam.
- You will have a neurological exam.
- You will complete the same questionnaires as before.
Length of Study Participation:
Your participation in the study will be over after your follow-up visit.
You will be taken off study if during surgery the doctor thinks the navigation is not accurate, you are injured related to an inaccurate image guidance, or your surgery is stopped.
This is an investigational study. The MRIs and x-rays on this study are performed using FDA-approved and commercially available methods. The use of MRI as image guidance for spinal surgery is investigational.
Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Spinal Tumor
- Being tested
- Magnetic Resonance Imaging (MRI), Questionnaires
- Keywords
- Epidural metastasis, Magnetic resonance imaging, MRI, Guidance system, Spinal surgery, Questionnaires, Surveys
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
MRI images of the spine taken of anesthetized participant in the operative prone position.
QuestionnairesBehavioural
Also called Surveys
Pain and symptom questionnaires completed at baseline and at follow up.
| Study group | Role | What they receive |
|---|---|---|
| MRI-Based Image Guidance | Experimental | MRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery.
Pain and symptom questionnaires completed at baseline and at follow up. Receives: Procedure: Magnetic Resonance Imaging (MRI); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety determined by 0% frequency of intraoperative and perioperative adverse events
Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
Measured: 3 weeks
Secondary outcomes (1)
Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
Navigation considered inaccurate if there is a discrepancy of more than 2mm between the real position of the probe confirmed by direct visual inspection, and the computer model displayed on the navigation screen.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start18 Dec 2015
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio E. Tatsui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613390
- Sponsor's protocol ID
- 2015-0481
- Other IDs
- NCI-2015-02277
- Status last verified
- Jan 2019
- First submitted
- 20 Nov 2015
- Last updated
- 10 Jan 2019
- 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 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Safety of Intraoperative MRI-Based Image Guidance for Laser Ablation of Epidural Metastasis
- ClinicalTrials.gov ID
- NCT02613390
- Acronym / sponsor ID
- 2015-0481
- Conditions
- Spinal Tumor
- Keywords
- Epidural metastasis, Magnetic resonance imaging, MRI, Guidance system, Spinal surgery, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 24 Nov 2015 (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.
The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine.
Detailed description
Study Visits:
If you agree to take part in this study, before your surgery:
- You will have a physical exam.
- You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes).
- You will complete questionnaires about pain and other symptoms that should take about 10-15 minutes.
- You will sign a separate consent for your spinal surgery that explains the risks.
During the Surgery:
You will be positioned lying face down on your stomach during surgery. While you are under anesthesia, an MRI will be used to take images of your spine. This is an intraoperative MRI, meaning that it is performed in a special magnet located inside a specifically designed operating room. These images will be loaded into a computer navigation program and will be used to help the doctor perform surgery.
Markers will also be attached to the skin of your back. These markers are used together with the navigation program and MRI images to record the location of where on your spine the doctor should cut. This recording will be compared to the MRI images.
Your doctor will check the accuracy of this recording in 2 ways:
- Placing the tip of the navigation probe on your skin and comparing it with the computer calculation in the computer navigation program. This is a standard navigation probe commonly used in spinal surgeries.
- Inserting the navigation probe through a small cut on your skin along the surgical area and taking an x-ray image of its location.
If there is a difference in the result of these 2 measurements, your doctor will use the result of the first step to check the accuracy of the MRI image.
If there is more than 2 millimeter difference between the visual inspection position and the computer model position, your doctor may decide to do one of the following steps:
- Restart the recording process by getting a new MRI image
- Use only the x-ray images to complete the procedure
- Stop the surgery
On the Day After Surgery:
- You will have a physical exam.
- You will have a neurological exam.
- You will complete the same questionnaires as before.
Follow-Up Visits:
The research staff will call you 3 weeks after surgery to ask about your recovery and you will be asked to answer the same questionnaires as before.
You will return for a follow-up visit after surgery:
- You will have a physical exam.
- You will have a neurological exam.
- You will complete the same questionnaires as before.
Length of Study Participation:
Your participation in the study will be over after your follow-up visit.
You will be taken off study if during surgery the doctor thinks the navigation is not accurate, you are injured related to an inaccurate image guidance, or your surgery is stopped.
This is an investigational study. The MRIs and x-rays on this study are performed using FDA-approved and commercially available methods. The use of MRI as image guidance for spinal surgery is investigational.
Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-Based Image Guidance | Experimental | Procedure: Magnetic Resonance Imaging (MRI), Behavioral: QuestionnairesMRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery. Pain and symptom questionnaires completed at baseline and at follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age =/> 18 years old.
- Must have epidural metastasis to be treated with MRI-guided laser ablation.
- Vertebral body site to be treated is located from C3 to L5.
- Signed informed consent.
Key exclusion criteria (4 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 of the spine.
- Pregnant female.
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 Imaging (MRI)Also: MRIMRI images of the spine taken of anesthetized participant in the operative prone position. | Procedure or surgery | MRI-Based Image Guidance |
| QuestionnairesAlso: SurveysPain and symptom questionnaires completed at baseline and at follow up. | Behavioural | MRI-Based Image Guidance |
Primary outcome
Safety determined by 0% frequency of intraoperative and perioperative adverse events
Time frame: 3 weeks
Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
1 secondary outcome
Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
Time frame: 1 day
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 Jan 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink 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, MD 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 study testing Magnetic Resonance Imaging (MRI) and Questionnaires in people with Spinal Tumor, 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 4 inclusion and 4 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 Jan 2019. 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?
Safety determined by 0% frequency of intraoperative and perioperative adverse events (time frame: 3 weeks). 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 Jan 2019.