A Prospective Interventional Study to Evaluate the Efficacy and Safety of Intraoperative Fluorescence Diagnosis Using 5-ALA in Meningioma surgery

Masahide Matsuda0 个研究点目标入组 22 人开始时间: 2021年6月22日最近更新: 2023年10月17日

适应症

试验速览

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•Patients who meet all of the following criteria are eligible
•1) Patients undergoing surgical removal of a first or recurrent (regardless of prior treatment, any number of recurrences are acceptable) brain tumor with meningioma as the primary differential.
•2) Patients scheduled for maximal resection by surgery (excluding biopsy, etc.)
•3) Age 20 years or older on the date of consent, regardless of gender.
•4) Either (a) or (b) below applies.
•(a) Most suspicious for recurrent meningioma
•(b) One or more of the following imaging findings on preoperative imaging: infiltration of the surrounding brain or bone, hyperostosis or bony destruction of the surrounding skull, extracranial extension of the tumor, marked cerebral edema around the tumor, cystic change within or around the tumor, irregularity of the tumor border, presence of peritumoral satellite lesions.
•5) Patients who have received sufficient explanation and understanding of the contents of this study, and who have given written consent of their own free will (substitute consent is not permitted, but substitute writing is permitted for patients who have difficulty writing due to paralysis, etc.)

•Patients with any of the following conditions will not be included in this study
•1) Patients with hypersensitivity to 5-ALA or porphyrins
•2) Patients with porphyria or a history of photosensitivity
•3) Patients who have received 5-ALA or Talaporfin sodium within one month of the scheduled administration of the study drug
•4) Patients with serious conditions or complications of systemic diseases that may interfere with the safe performance of general anesthesia or craniotomy
•5) Patients with serious cardiovascular diseases (myocardial infarction, unstable angina, valvular disease, heart failure, etc.) that require special attention in perioperative management
•6) Patients with serious liver disease or liver enzyme abnormalities [AST (GOT) or ALT (GPT) 100 IU/L or higher]
•7) Patients with serious renal dysfunction (serum creatinine 1.5 mg/dL or higher)
•8) Positive for HBs antigen, HCV antibody, or HIV antibody
•9) Women who are pregnant or may become pregnant
•10) Women who are breastfeeding
•11) Patients who are unable to undergo contrast-enhanced MRI
•12) Patients who are unable to take medication
•13) The most recent body weight measured within one month prior to surgery exceeds 75 kg
•14) Patients who have received any other study drug or investigational drug within 3 months of the scheduled administration of the study drug
•15) Other patients who are judged by the principal investigator to be ineligible as subjects

发起方

Masahide Matsuda