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

November 9, 2022 updated by: Nova Scotia Health Authority

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2Y5
        • Capital District Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those patients referred for MIBG assessment.

Description

Inclusion Criteria:

  • Patients with potential Adrenergic pathology

Exclusion Criteria:

  • Pregnant or breast feeding females
  • Hypersensitivity to MIBG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Administration of 123Iodine MIBG to the patients referred .
Drug: Administration of 123Iodine MIBG
Patients will be administered the locally produced 123 Iodine MIBG
Other Names:
  • None applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile of the 123Iodine MIBG
Time Frame: BP and Heart rate for 24 hours after injection.
BP and Heart rate for 24 hours after injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Andrew Ross, MD, Division Head, Nuclear Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2006

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 123Iodine MIBG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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