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

Phase 1

• Conditions: Intracranial tumor; MedDRA version: 20.0Level: LLTClassification code 10006153Term: Brain tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004512-58-DE
• Lead Sponsor: Technische Universität München, Fakultät für Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified