Primary Malignant Neoplasm of Nervous SystemIMAGERNCT01798771
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
A study testing Interventional arm in people with Primary Malignant Neoplasm of Nervous System and Glioma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Malignant Neoplasm of Nervous System, Glioma, Glioblastoma
- What is being tested?
- Interventional arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Feb 2016
- 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
- adult patient (> 18 years) able to give informed consent
- primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
- tumor must be deemed completely resectable by neurosurgeon
- diagnostic MRI
Who cannot join
- patient unable or unwilling to give informed consent
- infratentorial tumor location
- tumor location in or near eloquent areas
- multifocal tumor
- existance of contraindications to undergo MRI examination
- previous surgical treatment for an intraaxial brain tumor
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Neurochirurgie Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, 60528
Christian Senft, MD PhD, 069-6301 ext. 5939, c.senft@med.uni-frankfurt.de
About this study
The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
- Being tested
- Interventional arm, Control arm
- Keywords
- primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA
- Medical subject headings
- Glioma, Glioblastoma, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional armProcedure or surgery
Also called 5-ALA, 5-Aminolevulinic acid hydrochloride
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
Control armProcedure or surgery
Also called 5-ALA, 5-Aminolevulinic acid hydrochloride
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | 5-ALA fluorescence guided surgery in patients with contrast enhancing tumors. Receives: Procedure: Control arm |
| Interventional arm | Other | 5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors. Receives: Procedure: Interventional arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Resection
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.
Measured: Early postoperative MRI within 72 hrs
Secondary outcomes (4)
Volumetric extent of resection
Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.
Measured: Early postoperative MRI within 72hrs
PFS 6
Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection
Measured: 6 months following surgery
PFS 12
Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection
Measured: 12 months following surgery
Quality of life
Patient quality of life at 6 and 12 months following surgery is a secondary endpoint
Measured: 6 months/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Malignant Neoplasm of Nervous SystemStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Senft, Johann Wolfgang Goethe University Hospital
- Investigators
- Christian Senft, MD PhD, Principal investigator, Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798771
- Sponsor's protocol ID
- JohannWGUH_IMAGER
- Other IDs
- 206/12
- Acronym
- IMAGER
- Status last verified
- Feb 2013
- First submitted
- 22 Feb 2013
- Last updated
- 26 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT01798771
- Acronym / sponsor ID
- IMAGER / JohannWGUH_IMAGER
- Keywords
- primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 26 Feb 2013 (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 investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Procedure: Control arm5-ALA fluorescence guided surgery in patients with contrast enhancing tumors. |
| Interventional arm | Other | Procedure: Interventional arm5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patient (> 18 years) able to give informed consent
- primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
- tumor must be deemed completely resectable by neurosurgeon
- diagnostic MRI
Key exclusion criteria (6 listed)
- patient unable or unwilling to give informed consent
- infratentorial tumor location
- tumor location in or near eloquent areas
- multifocal tumor
- existance of contraindications to undergo MRI examination
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 |
|---|---|---|
| Interventional armAlso: 5-ALA, 5-Aminolevulinic acid hydrochloride5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors. | Procedure or surgery | Interventional arm |
| Control armAlso: 5-ALA, 5-Aminolevulinic acid hydrochloride5-ALA fluorescence guided surgery in patients with contrast enhancing tumors. | Procedure or surgery | Control arm |
Primary outcome
Extent of Resection
Time frame: Early postoperative MRI within 72 hrs
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.
4 secondary outcomes
Volumetric extent of resection
Time frame: Early postoperative MRI within 72hrs
PFS 6
Time frame: 6 months following surgery
PFS 12
Time frame: 12 months following surgery
Quality of life
Time frame: 6 months/12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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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.
Christian Senft, MD PhD principal investigator
Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional arm in people with Primary Malignant Neoplasm of Nervous System and Glioma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 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 26 Feb 2013. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Senft, MD PhD (069-6301 ext. 5939, c.senft@med.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of Resection (time frame: Early postoperative MRI within 72 hrs). 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 26 Feb 2013.