Efficacy of Intraoperative Fluorescence Diagnosis in Meningioma surgery

JRCT ID: jRCTs031210158

Registered date:22/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: meningioma
• Date of first enrollment: 14/02/2022
• Target sample size: 22
• Study type: Interventional
• Intervention(s): 5-ALA (Alabel) is administered and fluorescence imaging is performed intraoperatively to assess the presence and location of residual tumor.

Outcome(s)

• Primary Outcome: Percentage of cases in which 5-ALA fluorescence allowed for additional tumor removal
• Secondary Outcome: Tumor positive diagnosis rate of additionally removed specimens using fluorescence as an indicator, positive fluorescence diagnosis rate of tumor body, correlation between fluorescence intensity (qualitative evaluation of negative, vague, and strong) and pathological findings, positive fluorescence diagnosis rate of extension along the dura, positive rate of fluorescence in dural infiltration, positive rate of fluorescence in bone infiltration, positive rate of fluorescence in brain infiltration, positive rate of fluorescence in soft tissue infiltration, evaluation of molecules associated with fluorescence expression using tumor specimens, evaluation of the relationship between preoperative imaging findings and the usefulness of fluorescence diagnosis, adverse events within 1 week of study drug administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.)

Exclude criteria

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

Related Information

• Primary Sponsor: Masahide Matsuda