Post-marketing surveillance of Raiatt MIBG-I 131 Injection (all-case surveillance)

JRCT ID: jRCT2031220066

Registered date:17/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: MIBG accumulation positive and unresectable Pheochromocytoma / Paraganglioma
• Date of first enrollment: 11/04/2022
• Target sample size: 70
• Study type: Observational

Outcome(s)

Primary Outcome

1. Case composition
- Number of registered cases, number of cases for which questionnaires were collected, number of cases for safety analysis, number of cases for efficacy analysis
- Number of cases excluded from analysis and reasons for exclusion
- Number of institutions (contract, registration)
2. safety items
- The rate of adverse drug reactions
- The rate of serious adverse drug reactions
3. Efficacy
- Efficaacy evaluation (effect on tumor, transition of clinical symptoms)
Every time, after about 3 months from administration of Raiatt MIBG-I 131 Injection, the investigator evaluates the Raiatt MIBG-I 131 Injection's effect on the tumor and transition in clinical symptoms in this study, in comparison with before the first administration of Raiatt MIBG-I 131 Injection.
- Effect on tumor (evaluation by 123I-MIBG scintigraphy)
- Effect on tumor (evaluation by morphological image diagnosis [CT, MRI, etc.])
- Transition of clinical symptoms

• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: All patients who received Raiatt MIBG-I 131 Injection
• Exclude criteria: none

Related Information

• Primary Sponsor: Bando Kazunori