JPRN-jRCTs031180360
Completed
Phase 1
Photodynamic Therapy (PDT) for malignant brain tumor in children.
kawamata takakazu0 sites5 target enrollmentStarted: March 18, 2019Last updated:
ConditionsMalignant brain tumor in children
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- kawamata takakazu
- Enrollment
- 5
Overview
Brief Summary
We conducted a phase I/II clinical study of PDT for malignant brain tumors in children. No adverse events corresponding to CTCAE grade 3 or higher were observed, indicating that TS can be used safely in children. However, the efficacy of PDT, another objective of this study, could not be demonstrated due to the small number of cases and the diverse clinical backgrounds, including histological diagnosis and treatment received.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 6age to 20age (—)
- Sex
- All
Inclusion 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.
Exclusion 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.
Investigators
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