Glioma
Conditions
Keywords
intraoperative MRI, glioma surgery, extent of resection
Brief summary
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.
Interventions
PROCEDUREintraoperative MRI-guided tumor resection
tumor resection with the use of an intraoperative MRI
PROCEDUREstandard microsurgery
microsurgical tumor resection
Sponsors
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* known or suspected contrast-enhancing glioma (primary and recurrent) * location of the tumor permits intended gross-total resection
Exclusion criteria
* tumor location prohibits or questions gross-total resection * contraindications to undergo MRI examinations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Resection | 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 6 months | Progression-free survival (radiological and/or clinical progression) at 6 months following surgery |
| Volumetric Assessment | 72 hours | Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI |
| Neurological Deficit | 7 days | Assessment of new postoperative deficits following tumor surgery |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative MRI tumor resection with intraoperative MRI-guidance | 29 |
| Conventional Group standard microsurgical tumor resection | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Conventional Group | Intraoperative MRI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 13 |
| Region of Enrollment Germany | 29 participants | 29 participants | 58 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
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
Time frame: 72 hours
Population: Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative MRI | Extent of Resection | 24 participants |
| Conventional Group | Extent of Resection | 25 participants |
Secondary
Neurological Deficit
Assessment of new postoperative deficits following tumor surgery
Time frame: 7 days
Secondary
Progression-free Survival
Progression-free survival (radiological and/or clinical progression) at 6 months following surgery
Time frame: 6 months
Secondary
Volumetric Assessment
Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI
Time frame: 72 hours