Toyama Oncothermia Study for Intractable Malignant Brain Tumor
Phase 1
- Conditions
- Malignant brain tumor
- Registration Number
- JPRN-UMIN000022478
- Lead Sponsor
- Toyama University Hospital
- Brief Summary
ot yet
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1) Infected patients 2) Malnutrition 3) Severe comorbid such as heart disorders, colon dysfunction, lung fibrosis, uncontrolled diabetes mellitus, and chronic renal failure 4) Psychological disorders 5) Pregnancy 6) Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Outcome Clinical outcome is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) on MRI and is categorized into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). 2) Incidence of the following adverse events a) General condition Fatigue, fever, headache, hypotension, bradycardia, respiratory distress, allergic reaction b) Local condition Local pain, dermatitis, skin necrosis c) Laboratory examinations RBC, Hb, WBC, platelet, ALT (GOT), AST (GPT), LDH, T-bil, Cr d) Others
- Secondary Outcome Measures
Name Time Method 1) Karnofsky performance status (KPS) 2) Pre- and post-treatment radiological findings a) MRI b) MRS c) 201Tl SPECT d) 16F-FDG PET