Prospective study of I-131 3-iodobenzylguanidine radiotherapy for high-risk neuroblastoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
- Conditions
- euroblastoma
- Registration Number
- JPRN-UMIN000025045
- Lead Sponsor
- Kanazawa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 8
Not provided
1) active double cancer 2) diffuse bone marrow involvement on a 123I-MIBG scan 3) Progressive disease 4) HBV (or carrier), HCV, HIV, or other active infections 5) history of fatal arrhythmia or asystole 6) concurrent poorly-controlled symptomatic arrhythmia, thyroid dysfunction, respiratory disorder, pleural effusion, or ascites. 7) concurrent coronary artery disease, usage of amiodarone, severe cardiac valvulopathy, aortic disease, or bleeding tendency. 8) woman during pregnancy or lactation, within the 28 postpartum day, desiring pregnancy within 1 year. 9) concurrent poorly-controlled psychiatric disorder 10) allergy to potassium iodide. 11) difficult to cooperate with the radiation safety isolation. 12) concurrent palliative external radiotherapy to painful lesions. 13) past treatment by the same regimen as this study. 14) be unable to receive at least of 444MBq/kg of MIBG due to exceeding of upper limit of radiation use at the center. As the upper limit of our center is 24,000MBq, the patient over 54kg is excluded. 15) Patients who, in the opinion of the attending physician, may not be able to comply with the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method