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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031220066

Enrollment

Registered

2022-05-17

Start date

2022-04-11

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

MIBG accumulation positive and unresectable Pheochromocytoma / Paraganglioma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who received Raiatt MIBG-I 131 Injection

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
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 - Clinical tests for efficacy evaluation (Blood pressure, pulse rate, blood catecholamines, urinary catecholamines) - 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	—

Measure

Time frame

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 - Clinical tests for efficacy evaluation (Blood pressure, pulse rate, blood catecholamines, urinary catecholamines) - 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

—

Contacts

Public ContactManager of Potmarketing surveillane

PDRadiopharma Inc.

s-raiatt-mibg_gpsp@pdradiopharma.com+81-3-6263-0831

Outcome results