Adrenergic PathologyNCT01912040
Study Of the Safety of Locally Manufactured 123I-metaiodobenzylguanidine(MIBG) in Routine Clinical Use
An observational study of Adrenergic Pathology, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice to help in patient management decisions. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Adrenergic Pathology
- What is being tested?
- Administration of 123Iodine MIBG
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those patients referred for MIBG assessment.
Who may be able to join
- Patients with potential Adrenergic pathology
Who cannot join
- Pregnant or breast feeding females
- Hypersensitivity to MIBG
Trial locations and contacts
1 site in 1 country.
About this study
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
Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice to help in patient management decisions.
Read the 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.
- Conditions
- Adrenergic Pathology
- Being tested
- Administration of 123Iodine MIBG
- Keywords
- Safety profile, locally produced 123 Iodine MIBG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of 123Iodine MIBGDrug
Also called None applicable
Patients will be administered the locally produced 123 Iodine MIBG
| Study group | Role | What they receive |
|---|---|---|
| Patients | Administration of 123Iodine MIBG to the patients referred . Receives: Drug: Administration of 123Iodine MIBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of the 123Iodine MIBG
Measured: BP and Heart rate for 24 hours after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2006 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Issues with obtaining precursor materials for synthesis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenergic PathologyStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Ross, MD, Principal investigator, Division Head, Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912040
- Sponsor's protocol ID
- 123Iodine MIBG
- Status last verified
- Jul 2013
- First submitted
- 12 Jul 2013
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01912040
- Acronym / sponsor ID
- 123Iodine MIBG
- Conditions
- Adrenergic Pathology
- Keywords
- Safety profile, locally produced 123 Iodine MIBG
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Issues with obtaining precursor materials for synthesis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 2006 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Administration of 123Iodine MIBGAdministration of 123Iodine MIBG to the patients referred . |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those patients referred for MIBG assessment.
Key inclusion criteria (1 listed)
- Patients with potential Adrenergic pathology
Key exclusion criteria (2 listed)
- Pregnant or breast feeding females
- Hypersensitivity to MIBG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of 123Iodine MIBGAlso: None applicablePatients will be administered the locally produced 123 Iodine MIBG | Drug | Patients |
Primary outcome
Safety profile of the 123Iodine MIBG
Time frame: BP and Heart rate for 24 hours after injection.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Ross, MD principal investigator
Division Head, Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenergic Pathology, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of the 123Iodine MIBG (time frame: BP and Heart rate for 24 hours after injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.