Protoporphyrin Imaging in Multispectral Evaluation of Resections

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Protoporphyrin Imaging in Multispectral Evaluation of Resections

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria:

- 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.

- MRI Findings: Patients must meet one of the following criteria: - 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).

- Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment.

- 5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery.

- Post-op MRI: Patients who are able to undergo pre- and postoperative MRI (standard of care at the center).

- Informed Consent: Patients who are able to understand and provide written informed consent prior to enrollment in the study.

- Eligibility for Multispectral Imaging: Patients whose surgical procedures allow for the use of multispectral imaging technology for tumor visualization.

- Performance Status: Patients with a Karnofsky Performance Status (KPS) of 60 or greater, indicating that they are capable of at least limited self-care.

- No Prior Treatment: Patients who have not received prior treatment for the current brain tumor, including surgery, radiotherapy, or chemotherapy.

Exclusion criteria:

- 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.

- Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration.

- Patients with severe comorbidities or other medical conditions that, in the investigator's opinion, would pose an unacceptable risk or compromise the safety of participation in the study.

- Patients with a Karnofsky Performance Status (KPS) below 60, indicating an inability to perform minimal self-care.

- Patients with a history of severe hepatic or renal impairment that may impact the metabolism of 5-ALA.

- Patients unable to undergo MRI imaging for any reason (e.g., presence of non-MRI-compatible implants).

- Patients unable to provide written informed consent due to cognitive, language, or other barriers.

- Patients with tumors located in regions where fluorescence imaging is not technically feasible or where the use of multispectral imaging could interfere with the standard surgical approach.

- Pregnancy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07021573
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University Innsbruck
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Austria, Germany, Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Additional Details

The clinical study is conducted in the post-market stage according to ISO 14155 Annex I.1 as it is performed with a CE marked microscope system. An additional component (CALLAO) will be added to the microscope. The intended use of the microscope as well as the surgical procedure remain unchanged by this addition. CALLAO allows for taking pictures of the situs in the OR which increases the surgery duration by <1min per picture. Therefore, this is a non-interventional study with a minimal burden to subjects. The clinical investigation is not for a conformity assessment purpose. The burden to subjects is non-interventional.

Arms & Interventions

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.

Interventions

Device: - KINEVO 900 S with BLUE 400

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.

Contact a Trial Team

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