Protoporphyrin Imaging in Multispectral Evaluation of Resections

Sponsor
Medical University Innsbruck
Study ID
NCT07021573
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • KINEVO 900 S with BLUE 400 — DEVICE
    The investigational device consists of a CE marked (MDR) surgical microscope KINEVO 900 S by Carl Zeiss Meditec AG, including the BLUE 400 fluorescence option. This microscope is equipped with an additional component (CALLAO), provided by the Carl Zeiss Meditec AG, that allows for extended, multispectral, image acquisition in the operating room. CALLAO consists of an optical setup with additional cameras, that can be mounted on the main system KINEVO 900 S, and a second light source for specific illumination during image acquisition with the CALLAO cameras.

Study Details

Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.

Key Dates

First listed
Jun 15, 2025
Start date
Sep 30, 2025
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
May 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Other: GMB like or LGG like
    There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement.

Primary Outcome Measure

Primary objective [ Time Frame: 12 months ]

Central Contacts

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