Skip to content

Phase II study of photodynamic therapy (PDT) for malignant meningioma

Phase II study of photodynamic therapy (PDT) for malignant meningioma - PDT for malignant meningioma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031156
Enrollment
35
Registered
2018-03-01
Start date
2018-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant/atypical meningioma

Interventions

1) The patient is over 20 year old, who has grade 2 or 3 recurrent meningioma, or is diagnosed with grade 2 or 3 meningioma in initial surgery and need additional resection. 2) A single intrave

Sponsors

Kobe University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Hospital inpatients over the age of 20 years (2) Patients who are diagnosed as primary or recurrent malignant meningioma (WHO grade 2 or 3), which needs resection. (3) The tumor will be able to be subtotally removed. (4) Residual tumor region will be able to be irradiated by laser. (5) Laser irradiation site do not include large cerebral arteries. (6) KPS>=60% (7) Organ Function: 1. WBC>= 3,000 /micro L 2. Hb>=8.0 g/dL 3. Plt>=100,000 /micro L 4. AST (GOT) <=100 IU/L 5. ALT (GPT) <=100 IU/L 6. serum Cr <= 1.5 mg/dL (8) Patients willing to participate in the trial and sign written informed consent

Exclusion criteria

Exclusion criteria: (1) Subject is known, suspected or has history of intolerance or allergy to Talaporfin Sodium. (2) Subjects with porphyria. (3) Severe liver and renal dysfunction. (4) Subject with allergies such as a drug hypersensitivity constitution. (5) Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study, as risks of fetal and teratogenic adverse effects of Talaporfin Sodiumare not known.

Design outcomes

Primary

MeasureTime frame
Progression free time of the laser irradiation site

Countries

Japan

Contacts

Public ContactSASAYAMA TAKASHI

Kobe University Hospital Neurosurgery

takasasa@med.kobe-u.ac.jp0783825966

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026