PheochromocytomaPhase 3NCT01373736
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
A Phase 3 study testing 123I-meta-iodobenzylguanidine in people with Pheochromocytoma and Neuroblastoma, run by Vancouver Coastal Health at 1 site in Canada.
Trial summary
The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pheochromocytoma, Neuroblastoma, Paraganglioma
- What is being tested?
- 123I-meta-iodobenzylguanidine
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must have a clinical indication for 123I-MIBG imaging to evaluate for the presence, extent, or status of neuroendocrine tumors;
- subjects must be able and willing to comply with study procedures.
Who cannot join
- Subjects with history of renal insufficiency (serum creatinine level > 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;
- Subjects unable to tolerate lying supine;
- Subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123I-MIBG administration. Where the assessment of the risk/benefit ration suggests the use of 123I-MIBG in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.
- Conditions
- Pheochromocytoma, Neuroblastoma, Paraganglioma, Medullary Thyroid Carcinoma, Carcinoid Tumors
- Being tested
- 123I-meta-iodobenzylguanidine
- Medical subject headings
- Pheochromocytoma, Neuroblastoma, Paraganglioma, Carcinoma, Medullary, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123I-meta-iodobenzylguanidineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Vancouver Coastal Health
- Sponsor type
- Other government
- Investigators
- Daniel Worsley, MD, Principal investigator, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373736
- Sponsor's protocol ID
- H10-02695
- Status last verified
- Jun 2011
- First submitted
- 13 Jun 2011
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT01373736
- Acronym / sponsor ID
- H10-02695
- Conditions
- Pheochromocytoma, Neuroblastoma, Paraganglioma, Medullary Thyroid Carcinoma, Carcinoid Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Vancouver Coastal HealthOther government
- First posted
- 15 Jun 2011 (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.
The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have a clinical indication for 123I-MIBG imaging to evaluate for the presence, extent, or status of neuroendocrine tumors;
- subjects must be able and willing to comply with study procedures.
Key exclusion criteria (3 listed)
- Subjects with history of renal insufficiency (serum creatinine level > 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;
- Subjects unable to tolerate lying supine;
- Subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123I-MIBG administration. Where the assessment of the risk/benefit ration suggests the use of 123I-MIBG in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.
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 |
|---|---|---|
| 123I-meta-iodobenzylguanidine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
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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.
Daniel Worsley, MD principal investigator
Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 123I-meta-iodobenzylguanidine in people with Pheochromocytoma and Neuroblastoma, run by Vancouver Coastal Health 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Worsley, MD (604-875-4629, worsley@triumf.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Jun 2011.