Study Of the Safety of Locally Manufactured 123I-metaiodobenzylguanidine(MIBG) in Routine Clinical Use

Adrenergic Pathology Clinical Trial

Official title:

A Prospective, Open Label, Single Arm Cohort Study to Assess the Frequency of Adverse Reactions of Locally Manufactured 123I-metaiodobenzylguanidine in Routine Clinical Use

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01912040
• Other study ID #: 123Iodine MIBG
• Status: Withdrawn
• Start date: July 2006
• Est. completion date: December 2018

Study information

• Verified date: July 2013
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice to help in patient management decisions.

Description:

We will be assessing for adverse reactions of patients injected with locally manufactured 123 Iodine MIBG. With monitoring of blood pressure and heart rate following injection and any potential immediate side effects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

Inclusion Criteria:

• Patients with potential Adrenergic pathology

Exclusion Criteria:

• Pregnant or breast feeding females

• Hypersensitivity to MIBG

Related Conditions & MeSH terms

• Adrenergic Pathology

Intervention

Drug:
• Administration of 123Iodine MIBG
Patients will be administered the locally produced 123 Iodine MIBG

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of the 123Iodine MIBG		BP and Heart rate for 24 hours after injection.