Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation

NCT04597801 | Completed Phase 2

• 1 other identifier: INV-GEM-0200-I
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

Brief Summary

With the appliance of the in-vivo microscopy after Fluorescein staining, the investigators hypothesize that the preliminary in-vivo histopathological diagnostic accuracy is not inferior to conventional frozen section analysis accuracy when using the final histopathological result as gold standard.

Conditions

Intracranial Tumor

Outcome Measures

Primary Outcomes (1)

• Significance: The diagnostic accuracies of the individual methods used for preliminary intraoperative histopathological diagnosis (D1:fluorescein sodium with in-vivo microscopy versus D2: preliminary frozen section assessment)

  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).

  14 days

Secondary Outcomes (2)

• Incidence of adverse events during surgery and until end of follow-up period (Safety Assessment)

  24 days

• 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.

  14 days

Study Arms (1)

Fluorescein sodium

EXPERIMENTAL

A single dose of fluorescein sodium is applied before brain tumor resection. 20-40 minutes prior to the planned tumor resection, a bolus of 5 mg per kg body weight is administered intravenously, staining tumor tissue with fluorescent dye to visualize tumor cells.

Drug: Alcon

Interventions

Alcon DRUG

Fluorescein sodium is administered intravenously with a bolus injection of 5 mg per kg of bodyweight 20-40 minutes prior to the planned tumor resection.

Also known as: Fluorescein sodium

Fluorescein sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Signed informed consent
• Suspected intracranial tumor revealed by cranial magnetic resonance imaging (according to clinical routine) scheduled for resection with intraoperative frozen section evaluation

You may not qualify if:

• Known allergic or suspected allergic reactions to fluorescein sodium
• Liver disease, CHILD B or C
• 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
• Patients with relevant congenital limitations of glucuronidation performance (e.g. Rotor syndrome, Gilbert-Meulengracht syndrome, Crigler-Najjar syndrome)
• Patients with terminal renal failure requiring hemodialysis
• Inability to provide informed consent
• Pregnancy (incl. positive pregnancy test)
• 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.

Sponsors & Collaborators

• Technical University of Munich: lead
• Carl Zeiss Meditec AG: collaborator

Study Sites (3)

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Technische Universität München, Klinik und Poliklinik für Neurochirurgie

München, 81675, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

methylacetylene; Fluorescein

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Jens PD Gempt, MD

  Technische Universität München, Klinik und Poliklinik für Neurochirurgie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 22, 2020
• Study Start: December 30, 2020
• Primary Completion: June 17, 2022
• Study Completion: August 3, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)