Neoplasms

Nervous System Diseases

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Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Subjects with unilateral intracranial tumor

Hugo Vereecke, MD PhD

Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.

Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia: Comparison With a Control Group Without Intracranial Pathology

Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia. Comparison With a Control Group Without Intracranial Pathology.

Medtronic - MITG

University Hospital, Ghent

Dipivefrin

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.

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.

Alcon

Jens PD Gempt, MD

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.

In neurosurgery, intraoperative histopathological frozen section analysis (cryosection) offers a crucial tool for the rapid assessment of tumor entity and dignity and the creation of tumor-free resection margins. The method, however, remains unreliable and time-consuming, sometimes prolonging surgical times and demonstrating diagnostic accuracy for frozen section in glioma ranging from 78.4% to 95% in comparison to the final histopathology, depending on the technique used.2,3 To combat these shortcomings, another promising adjunct was developed in the form of intraoperative dye-dependent in-vivo microscopy, for which there has been little scientific evidence so far, with only a few recent studies exploring its utility, safety and general applicability. The theoretical idea of the technique in principle is to allow for histopathological assessment of tumor tissue in-vivo without the need for time-consuming fixation and transport of resected tissue biopsies, aiming for a so-called in-situ digital biopsy and thereby substantially improving operative precision and surgical times. It stands to reason that the benefit in visualization provided by fluorescein staining may further be driven through in-vivo microscopy. Altogether, with the use of fluorescein sodium in in-vivo microscopy, the operating surgeon may in the future inspect supposedly malignant fluorescent tissue first-hand, evaluate it for tumorous cells in real-time and adjust their resection strategy in a far more immediate fashion.

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)

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).

To assess the safety of the Investigational Medicinal Product (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.

Carl Zeiss Meditec AG

Technical University of Munich

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Glioma

Mitral Valve Insufficiency

MRI at timepoints given above, neuropsychological testing after surgery, but before radiotherapy or chemotherapy.

Neuropsychological testing month 3 during treatment. Neuropsychological testing after 1 year. Neuropsychological testing after 2 years.

MRI, neuropsychological evaluation, blood sampling

Pia Maly Sundgren, MD. PhD

The main purposes with this trial is to investigate the potential of MRI with diffusion and blood volume, flow in brain to diagnose and to measure treatment effects in patients with intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate the possibilities to individually adjusted treatment in this category of patients depending on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI to evaluate a correlation and to perform testing of cognitive ability before, during, and after treatment and to investigate if given treatment causes any decrease in the patients habitual state.

Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters

Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters.

Neuropsychological testing to evaluate the correlation between MRI results and neuropsychological status in participating patients. This applies for 80 patients of 150 of the patient population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia: Comparison With a Control Group Without Intracranial Pathology	NCT00936806	Intracranial Tu...		18 Years - 80 Years	University Hospital, Ghent
Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation	NCT04597801	Intracranial Tu...	Alcon	18 Years -	Technical University of Munich
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters	NCT01674582	Intracranial Tu...	MRI, neuropsych...	18 Years -	Lund University Hospital
Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation	NCT04597801	Intracranial Tu...	Alcon	18 Years -	Technical University of Munich

Spots Global Cancer Trial Database for intracranial tumor