ALA-induced PpIX Fluorescence During Brain Tumor Resection

Study Overview
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Brief Summary
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Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.

Official Title
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Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection

Conditions
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Brain Tumors

Intervention / Treatment
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* Drug: 5-aminolevulinic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma Tumor judged to be suitable for open cranial resection based on preoperative imaging studies. Patient or LAR able to provide written informed consent. No serious associated psychiatric illnesses. Age > 21 years old. Exclusion Criteria: Pregnant women or women who are breast feeding History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis. History of liver disease within the last 12 months. Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery. Inability to comply with the photosensitivity precautions associated with the study. Plasma creatinine in excess of 180umol/L within 30 days prior to surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: 5-aminolevulinic acid<br>20mg/kg 3 hours prior to surgery | Drug: 5-aminolevulinic acid<br> <br> * Other names: 5-ALA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology | To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure | Up to five years from the first surgery date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence, Brain Tumors, Brain Metastases, Malignant Glioma, Brain Lesions