Trial Outcomes & Findings for Intraoperative MRI-guidance in Frameless Stereotactic Biopsies (NCT NCT01779219)
NCT ID: NCT01779219
Last Updated: 2016-02-15
Results Overview
The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.
Results posted on
2016-02-15
Participant Flow
Participant milestones
| Measure |
iMRI
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) was used in all cases.
|
Non-iMRI
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative MRI-guidance in Frameless Stereotactic Biopsies
Baseline characteristics by cohort
| Measure |
iMRI
n=21 Participants
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with was used in all procedures.
|
Non-iMRI
n=21 Participants
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 17 • n=99 Participants
|
55 years
STANDARD_DEVIATION 15 • n=107 Participants
|
54 years
STANDARD_DEVIATION 16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
ECOG Performance Status
|
2 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
|
Maximum tumour diameter
|
48 mm
STANDARD_DEVIATION 19 • n=99 Participants
|
54 mm
STANDARD_DEVIATION 18 • n=107 Participants
|
51 mm
STANDARD_DEVIATION 18 • n=206 Participants
|
|
Tumour enhancement
Enhancement noted
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Tumour enhancement
No enhancement noted
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Basal localization
basal localisation of the tumor
|
7 participants
n=99 Participants
|
9 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Basal localization
non-basal localisation of the tumor
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Thalamic localization
thalamic localisation of the tumor
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Thalamic localization
extra-thalamic localisation of the tumor
|
19 participants
n=99 Participants
|
17 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Diabetes
Diabetes recorded
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Diabetes
Diabetes not recorded
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.Population: Complications assessed: Haematoma, Neurological deterioration, Infection
The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.
Outcome measures
| Measure |
iMRI
n=21 Participants
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures.
|
Non-iMRI
n=21 Participants
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
|
|---|---|---|
|
Number of Participants Presenting With Complications
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: For each patient 2 weeks after the operationThe diagnostic yield is expressed as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the operation.
Outcome measures
| Measure |
iMRI
n=21 Participants
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures.
|
Non-iMRI
n=21 Participants
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
|
|---|---|---|
|
Diagnostic Yield
|
20 participants
|
20 participants
|
SECONDARY outcome
Timeframe: From date of hospitalization until the date of discharge, assessed up to 2 days.The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)
Outcome measures
| Measure |
iMRI
n=21 Participants
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures.
|
Non-iMRI
n=21 Participants
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
|
|---|---|---|
|
Length of Hospital Stay
Total length of hospital stay
|
5 days
Interval 2.0 to 13.0
|
7 days
Interval 1.0 to 18.0
|
|
Length of Hospital Stay
The length of preoperative hospital stay
|
3 days
Interval 0.0 to 8.0
|
4 days
Interval 0.0 to 8.0
|
|
Length of Hospital Stay
The length of postoperative hospital stay
|
2 days
Interval 1.0 to 6.0
|
2 days
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation.the preparation (Tprep), operation (Top) and total operating room (TOR) time
Outcome measures
| Measure |
iMRI
n=21 Participants
The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.
Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures.
|
Non-iMRI
n=21 Participants
A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
|
|---|---|---|
|
Time
Total OR time
|
111 minutes
Standard Deviation 24
|
78 minutes
Standard Deviation 29
|
|
Time
Time of preparation
|
53 minutes
Standard Deviation 22
|
34 minutes
Standard Deviation 20
|
|
Time
Time of the operation
|
60 minutes
Standard Deviation 26
|
44 minutes
Standard Deviation 20
|
Adverse Events
iMRI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-iMRI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marcin Czyz
Wroclaw University Hospital, Department of Neurosurgery
Phone: +48 734-34-00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place