Vestibular SchwannomaNCT03097822
Response Prediction After GKS in Patients With Vestibular Schwannoma Using DCE MR Imaging
An observational study of Vestibular Schwannoma, run by Seoul National University Hospital.
Trial summary
Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vestibular Schwannoma
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with vestibular schwannoma, who underwent gamma knife surgery
Who may be able to join
- Patients with vestibular schwannoma, who underwent gamma knife surgery and pre-op dynamic contrast enhanced (DCE) MRI
- Patients with vestibular schwannoma, who received consent
Who cannot join
- In addition to the vestibular schwannoma, if the brain has other underlying or systemic disease
- During the observation period, other treatments were performed other than gamma knife surgery
- If patients have a contraindication to MRI (eg, pacemaker, cochlear implants, hemodynamically unstable)
- Concomitant use of gadolinium MRI contrast agents (eg, renal insufficiency [glomerular filtration rate <30 ML / min]), or if there was a side effect when using a contrast medium.
- Adults with impaired ability to cope
- If the images and medical records required for this study are not available or are not appropriate
Trial locations and contacts
No sites are listed yet.
SeungHong Choi, MD,PhD contact
About this study
Official title: Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging
Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging
Read the detailed description
The purpose of this study was to evaluate the response of Gamma Knife Surgery to Ktrans, Ve, and Vp, which are indicators of permeability map obtained from dynamic contrast enhanced (DCE) MRI in patients with vestibular schwannoma .
- Conditions
- Vestibular Schwannoma
- Medical subject headings
- Neuroma, Acoustic
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size change before and after surgery
Measured: pre-op, Immediately after surgery
Secondary outcomes (1)
In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJan 2017
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Hong Choi, Seoul National University Hospital
- Investigators
- SeungHong Choi, MD,PhD, Principal investigator, Seoul National University Hospital(Radiology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097822
- Sponsor's protocol ID
- H-1611-087-809
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging
- ClinicalTrials.gov ID
- NCT03097822
- Acronym / sponsor ID
- H-1611-087-809
- Conditions
- Vestibular Schwannoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- First posted
- 31 Mar 2017 (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.
Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging
Detailed description
The purpose of this study was to evaluate the response of Gamma Knife Surgery to Ktrans, Ve, and Vp, which are indicators of permeability map obtained from dynamic contrast enhanced (DCE) MRI in patients with vestibular schwannoma .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with vestibular schwannoma, who underwent gamma knife surgery
Key inclusion criteria (2 listed)
- Patients with vestibular schwannoma, who underwent gamma knife surgery and pre-op dynamic contrast enhanced (DCE) MRI
- Patients with vestibular schwannoma, who received consent
Key exclusion criteria (6 listed)
- In addition to the vestibular schwannoma, if the brain has other underlying or systemic disease
- During the observation period, other treatments were performed other than gamma knife surgery
- If patients have a contraindication to MRI (eg, pacemaker, cochlear implants, hemodynamically unstable)
- Concomitant use of gadolinium MRI contrast agents (eg, renal insufficiency [glomerular filtration rate <30 ML / min]), or if there was a side effect when using a contrast medium.
- Adults with impaired ability to cope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor size change before and after surgery
Time frame: pre-op, Immediately after surgery
1 secondary outcome
In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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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.
SeungHong Choi, MD,PhD contact
SeungHong Choi, MD,PhD principal investigator
Seoul National University Hospital(Radiology)
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Schwannoma, run by Seoul National University Hospital.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SeungHong Choi, MD,PhD (verocay@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor size change before and after surgery (time frame: pre-op, Immediately after 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 31 Mar 2017.