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 — DEVICEThe 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 likeThere 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
- Christian Freyschlag, Prof. Dr.+43 (0)51250427463
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