Clinical Trial Results:
Comparison of Fluorescein-INtra-VItal microscopy Versus conventional frozen section diagnosis for intraOperative histopathological evaluation
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Summary
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EudraCT number |
2019-004512-58 |
Trial protocol |
DE |
Global end of trial date |
17 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Jul 2023
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First version publication date |
15 Jul 2023
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Other versions |
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Summary report(s) |
CSR_INVIVO |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
INV-GEM-0200-I
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04597801 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Technische Universität München, Fakultät für Medizin
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Sponsor organisation address |
Ismaninger Str. 22, München, Germany, 81675
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Public contact |
Helen Bidner, Münchner Studienzentrum, 0049 8941406312, helen.bidner@mri.tum.de
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Scientific contact |
Prof. Dr. med. Jens Gempt, Klinik und Poliklinik für Neurochirurgie , 0049 8941402151, nch-office@mri.tum.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Jun 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Jun 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Jun 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the clinical trial is to compare the significance of intravenously applied fluorescein as staining agent for assessment of brain tissue texture via in-vivo confocal microscopy with the conventional intraoperative histological frozen section analysis of identical brain tissue samples in the same patient. Both methods will be compared in terms of their accuracy using the standard of practice, the final pathological diagnosis (immunochemistry/molecular pathology).
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP).
All participants have been informed in detail about the clinical trial in a personal interview. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision.
The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Nov 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 210
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Worldwide total number of subjects |
210
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EEA total number of subjects |
210
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
123
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From 65 to 84 years |
84
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85 years and over |
3
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Recruitment
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Recruitment details |
The study was conducted multicentric (3 study sites) in Germany. The recruitment took place between November 30, 2020 (first patient recruited) and June 30, 2022 (last patient completed) | ||||||||||||||||
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Pre-assignment
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Screening details |
During Screening, the preoperative routine measures (demographics, medical/surgical history and pregnancy test) are carried out and in addition the inclusion-, exclusion criteria have to be checked and the ICF must be obtained before each study specific procedure. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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All patients | ||||||||||||||||
Arm description |
Contains all patients who entered the study | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Fluorescein Alcon 10%
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Investigational medicinal product code |
SUB13905MIG
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Other name |
FLUORESCEIN SODIUM
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
5mg per kg bodyweight
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
FAS
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The full analysis set consists of all patients who entered the clinical trial, received Fluorescein, and had surgery. Patients with missing primary endpoint assessments were excluded from this analysis set.
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Subject analysis set title |
PPS
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The per-protocol set consists of all patients in the FAS who had no major protocol violations.
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End points reporting groups
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Reporting group title |
All patients
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Reporting group description |
Contains all patients who entered the study | ||
Subject analysis set title |
FAS
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The full analysis set consists of all patients who entered the clinical trial, received Fluorescein, and had surgery. Patients with missing primary endpoint assessments were excluded from this analysis set.
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Subject analysis set title |
PPS
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol set consists of all patients in the FAS who had no major protocol violations.
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End point title |
Difference in accuracy [1] | ||||||||||||
End point description |
The accuracy of Convivo and the accuracy of Frozen Section were computed and their difference is presented including a 95%CI. The Non-inferiority margin was -0.05. As the lower boundary of the CI is below -0.05, non-inferiority of Convivo over Frozen Section could not be shown.
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End point type |
Primary
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End point timeframe |
Measured at study end
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: n.a. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Duration of Convivo assessments | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Collected during surgery
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| No statistical analyses for this end point | |||||||||
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End point title |
Duration of frozen section analysis | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Collected during surgery
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
The Adverse Events have been reported at begin of visit 1 (baseline) and ended at visit 3.
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Adverse event reporting additional description |
Some hospital admissions, as defined by the study protocol, were not considered SAEs.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
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Reporting groups
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Reporting group title |
Safety Analysis Set
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Reporting group description |
The safety analysis set contains all patients who received IMP. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
