Comparison of Fluorescein-INtra-VItal microscopy Versus conventional frozen section diagnosis for intraOperative histopathological evaluation

Comparison of Fluorescein-INtra-VItal microscopy Versus conventional frozen section diagnosis for intraOperative histopathological evaluation - INVIVO

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004512-58-DE

Enrollment

200

Registered

2020-03-06

Start date

2020-08-17

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial tumor MedDRA version: 20.0 Level: LLT Classification code 10006153 Term: Brain tumor System Organ Class: 100000004864

Interventions

Trade Name: Fluorescein Product Name: Fluorescein Pharmaceutical Form: Solution for injection CAS Number: 518-47-8 Other descriptive name: FLUORESCEIN SODIUM Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Signed informed consent 3. Suspected intracranial tumor revealed by cranial magnetic resonance imaging (according to clinical routine) scheduled for resection with intraoperative frozen section Evaluation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Known allergic or suspected allergic reactions to fluorescein sodium 2. Liver disease, CHILD B or C 3. Patients under medication with beta-blockers, digoxin, chinidin and probenecid as well as inhibitors of glucuronidation, such as immunosuppressants, when the medication must not be discontinued perioperatively 4. Patients with relevant congenital limitations of glucoronidation performance (e.g. Rotor syndrome, Gilbert-Meulengracht syndrome, Crigler-Najjar syndrome) 5. Patients with terminal renal failure requiring hemodialysis 6. Inability to provide informed consent 7. Pregnancy (incl. positive pregnancy test) 8. Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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).;Secondary Objective: - To assess the safety of the IMP as staining agent for in-vivo confocal microscopy by documentation of adverse events during surgery and until end of follow-up period. - Analysis of surgical time span: comparison of the time span to conduct the assessment of brain tissue texture with fluorescein intervention with the time span to conduct assessment of conventional intraoperative frozen section intervention. ;Primary end point(s): To show non-inferiority of fluorescein staining before in-vivo confocal microscopy to histological frozen section in terms of accuracy accessed using the gold standard, post-surgery white light microscopy with immunochemistry.;Timepoint(s) of evaluation of this end point: histopathological microscopy and frozen section analysis will be done at visit 1 (surgery). Final histopathological result will be available at visit 3 (Days 4 to 10)	—

Measure

Time frame

Main Objective: 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).;Secondary Objective: - To assess the safety of the IMP as staining agent for in-vivo confocal microscopy by documentation of adverse events during surgery and until end of follow-up period. - Analysis of surgical time span: comparison of the time span to conduct the assessment of brain tissue texture with fluorescein intervention with the time span to conduct assessment of conventional intraoperative frozen section intervention. ;Primary end point(s): To show non-inferiority of fluorescein staining before in-vivo confocal microscopy to histological frozen section in terms of accuracy accessed using the gold standard, post-surgery white light microscopy with immunochemistry.;Timepoint(s) of evaluation of this end point: histopathological microscopy and frozen section analysis will be done at visit 1 (surgery). Final histopathological result will be available at visit 3 (Days 4 to 10)

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Secondary

Measure	Time frame
Secondary end point(s): - Adverse events will be recorded during surgery and until end of follow-up period - Surgical time span to conduct the assessment of brain tissue texture with fluorescein sodium intervention will be compared to the time span to conduct assessment of conventional frozen section intervention. ;Timepoint(s) of evaluation of this end point: - Adverse events will be recorded during surgery and until end of follow-up period - Evaluation of time span will be done during surgery	—

Measure

Time frame

Secondary end point(s): - Adverse events will be recorded during surgery and until end of follow-up period - Surgical time span to conduct the assessment of brain tissue texture with fluorescein sodium intervention will be compared to the time span to conduct assessment of conventional frozen section intervention. ;Timepoint(s) of evaluation of this end point: - Adverse events will be recorded during surgery and until end of follow-up period - Evaluation of time span will be done during surgery

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Countries

Germany

Contacts

Public ContactHelen Bidner

Münchner Studienzentrum

helen.bidner@mri.tum.de00498941406312

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026