Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597801
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2020-09-14
Brief Title:
Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Comparison of Fluorescein-INtra-VItal Microscopy Versus Conventional Frozen Section Diagnosis for intraOperative Histopathological Evaluation INVIVO
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INVIVO
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
Detailed Description:
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 784 to 95 in comparison to the final histopathology depending on the technique used23 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None