Study Of the Safety of Locally Manufactured 123I-metaiodo... | NCT01912040

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

NCT01912040

Sponsor

Nova Scotia Health Authority

Status

Withdrawn

Last Update Posted

Nov 14, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Adrenergic Pathology

Interventions

Administration of 123Iodine MIBG

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Issues with obtaining precursor materials for synthesis

Expanded Access Info

Start Date

Jul 2006Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 12, 2013

First Submission Date that Met QC Criteria

Jul 29, 2013

First Posted Date

Jul 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2022

Last Update Posted Date

Nov 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Administration of 123Iodine MIBG to the patients referred .	Drug: Administration of 123Iodine MIBG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Administration of 123Iodine MIBG	Drug	Patients will be administered the locally produced 123 Iodine MIBG	Patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with potential Adrenergic pathology

Exclusion Criteria:

Pregnant or breast feeding females
Hypersensitivity to MIBG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Those patients referred for MIBG assessment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Ross, MD	Division Head, Nuclear Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Capital District Health Authority		Halifax	Nova Scotia	B3H2Y5	Canada