CompletedPhase 2

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

Germany210 participantsStarted 2020-12-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

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)

Timeframe: 14 days

Trial details

NCT IDNCT04597801

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-17

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