Photodynamic Therapy (PDT) for malignant brain tumor in children.

JRCT ID: jRCTs031180360

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant brain tumor in children
• Date of first enrollment: 11/06/2018
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Medication: Talaporfin sodium (Leserphyrin)
Dose: Dose-up from 10mg/square-20mg/square-40mg/square in sequence in every 3 cases since initial enrolled case. Finally, single drip intra-venous infusion of 40mg/square is required.
Timing: 22-26 hours bafore surgical removal.

Laser irradiation in a wave length of 664+/-2nm for tumor removal cavity 22-26 hours after drip intra-venous infusion of Talaporfin sodium.

Outcome(s)

Primary Outcome

1. Safety (including photosensitivity test)(phase I)
2. Overall survival (OS) rate at 12 months after PDT (phase II)

Secondary Outcome

1. Overall survival (OS)
2. Progression-free survival (PFS) rate at 6 months after PDT.
3. Progression-free survival
4. Safety (including photosensitivity test)

Key inclusion & exclusion criteria

• Age minimum: 6age
• Age maximum: 20age
• Gender: Both

Include criteria

1. Patients treated at the department of neurosurgery, Tokyo Women's Medical University, Tokyo, Japan(in both outpatient clinic and admission).
2. Man and woman, over the age of 6 years old and below the age of 20 years old at enrollment.
3. In an initial case, patients who are highly suspicious for primary malignant brain tumor from pre-operative neuro-imaging. In a recurrent case, patient who is diagnosed as primary malignant brain tumor at previous histopathological diagnosis.

Exclude criteria

1. Patients without surgical tumor removal.
2. Unusable for Talaporfin Sodium.
3. Non intended histopathological types of brain tumor.
4. Patients necessary for VEP monitoring.
5. Pregnancy or possibility of pregnancy.
6. Patients who are expected poor compliance with light shielding protection.
7. Patients regarded as ineligible by principal investigator.

Related Information

• Primary Sponsor: kawamata takakazu
• Secondary ID(s): UMIN000030883