Protoporphyrin Imaging in Multispectral Evaluation of Resections

Launched by MEDICAL UNIVERSITY INNSBRUCK · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called multispectral imaging to see if it can help doctors better visualize brain tumors, specifically gliomas, during surgery. Gliomas are a type of brain tumor that can be difficult to see clearly with standard imaging methods. The goal is to improve how these tumors are identified and treated.

To be eligible for this study, participants must be 18 years or older, have a suspected high-grade glioma diagnosed through MRI imaging, and be scheduled for surgery to remove the tumor. They will also receive a special substance called 5-aminolevulinic acid (5-ALA) during surgery to help highlight the tumor. Participants will need to undergo both pre- and post-surgery MRI scans and must be able to give informed consent, which means they understand the study and agree to take part. The trial is not yet recruiting participants, but it aims to gather important information that could lead to better outcomes for patients with brain tumors in the future.

Gender

ALL

Eligibility 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