臨床研究等提出・公開システム

Date of registration	May. 17, 2022
Last modified on	July. 12, 2024
Trial ID	jRCT2031220066

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

Contact for Scientific Queries	Name	Namioka Hirotomo
	Affiliation	PDRadiopharma Inc.
	Address	2-14-1, Kyoubashi, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6263-0831
	E-mail	s-raiatt-mibg_gpsp@pdradiopharma.com
Contact for Public Queries	Name	Manager of Potmarketing surveillane
	Affiliation	PDRadiopharma Inc.
	Address	2-14-1, Kyoubashi, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-6263-0831
	E-mail	s-raiatt-mibg_gpsp@pdradiopharma.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 18, 2022
Actual date of first enrollment		April. 11, 2022
Target sample size		70
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	All patients who received Raiatt MIBG-I 131 Injection
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		MIBG accumulation positive and unresectable Pheochromocytoma / Paraganglioma
Primary Outcome(s)		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
Secondary Outcome(s)		none

Primary Sponsor	PDRadiopharma Inc.

Name of Certified Review Board	Not Applicable due to Observational Study
Address	none, Tokyo

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 12, 2024	(this page)	Changes
1	May. 17, 2022	Detail

List of change history