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NCT04597801: INVIVO

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

Completed Phase 2 Last updated 10 November 2022
What this trial tests

Phase 2 trial testing Alcon in Intracranial Tumor in 210 participants. Completed in 3 August 2022.

Timeline
30 December 2020
Primary endpoint
17 June 2022
3 August 2022

Quick facts

Lead sponsorTechnical University of Munich
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment210
Start date30 December 2020
Primary completion17 June 2022
Estimated completion3 August 2022
Sites3 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Technical University of Munich

Who can join

18 and older, any sex, with Intracranial Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Confocal laser imaging in neurosurgery: A comprehensive review of sodium fluorescein-based CONVIVO preclinical and clinical applications.
    Restelli F, Mathis AM, Höhne J, Mazzapicchi E, et al · · 2022 · cited 20× · PMID 36263218 · DOI 10.3389/fonc.2022.998384
  2. Intraoperative confocal laser endomicroscopy for brain tumors - potential and challenges from a neuropathological perspective.
    Maragkou T, Quint K, Pollo B, Hewer E. · · 2022 · cited 7× · PMID 37284159 · DOI 10.17879/freeneuropathology-2022-4369
  3. Current and Emerging Fluorescence-Guided Techniques in Glioma to Enhance Resection.
    Nguyen TTT, Mnatsakanyan H, Yi E, Badr CE. · · 2025 · cited 1× · PMID 40867331 · DOI 10.3390/cancers17162702

Verify or expand the search:

Other recruiting trials for Intracranial Tumor

Currently open trials in the same condition.

Other Technical University of Munich trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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