Protoporphyrin Imaging in Multispectral Evaluation of Resections
ConditionGlioma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMedical University Innsbruck
About this trial
Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age Requirement: Patients must be 18 years of age or older.
Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging.
Group 1: Suspected high-grade glioma with contrast enhancement on MRI (GBM-like).
Group 2: Suspected high-grade glioma without contrast enhancement on MRI (LGG-like).
Disqualifiers
Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components.
Use of all other fluorescent markers.
Patients with a history of porphyria or other disorders related to 5-ALA metabolism.
Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy.
Trial design
Design model
Sequential
Treatments tested in this trial
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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: GMB like or LGG likeOther 1 intervention
Trial outcomes
Primary outcomes
1
Primary objective
Detection of Tumor cells and fluorescence in biopsied tissue
Time frame
12 monthsSecondary outcomes
1
Secondary objectives
Correlation with Histopathology, Diagnostic Performance Metrics, Molecular or Cellular Characterization, Clinical Correlation, Imaging Technology Performance, Impact on Clinical Decision-Making
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: