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Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.
In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.
Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraoperative MRI | Active Comparator | tumor resection with intraoperative MRI-guidance |
|
| conventional group | Active Comparator | standard microsurgical tumor resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoperative MRI-guided tumor resection | Procedure | tumor resection with the use of an intraoperative MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Resection | Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival (radiological and/or clinical progression) at 6 months following surgery | 6 months |
| Volumetric Assessment | Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Senft, M.D. | Goethe University | Principal Investigator |
| Volker Seifert, M.D. | Goethe University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Goethe-University | Frankfurt | 60528 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21868284 | Result | Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraoperative MRI | tumor resection with intraoperative MRI-guidance |
| FG001 | Conventional Group | standard microsurgical tumor resection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intraoperative MRI | tumor resection with intraoperative MRI-guidance |
| BG001 | Conventional Group | standard microsurgical tumor resection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Extent of Resection | Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved | Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis. | Posted | Number | participants | 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intraoperative MRI | tumor resection with intraoperative MRI-guidance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christian Senft | Johann Wolfgang Goethe University | +49 69 63015939 | c.senft@med.uni-frankfurt.de |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| standard microsurgery | Procedure | microsurgical tumor resection |
|
| 72 hours |
| Neurological Deficit | Assessment of new postoperative deficits following tumor surgery | 7 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Progression-free Survival | Progression-free survival (radiological and/or clinical progression) at 6 months following surgery | Not Posted | 6 months |
| Secondary | Volumetric Assessment | Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI | Not Posted | 72 hours |
| Secondary | Neurological Deficit | Assessment of new postoperative deficits following tumor surgery | Not Posted | 7 days |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Conventional Group | standard microsurgical tumor resection | 0 | 25 | 0 | 25 |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |