Back to results123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
Primary Purpose
Pheochromocytoma, Neuroblastoma, Paraganglioma
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
123I-meta-iodobenzylguanidine
Sponsored by
About this trial
This is an interventional diagnostic trial for Pheochromocytoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.
Sites / Locations
- Vancouver Coastal Health
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01373736
Brief Title
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vancouver Coastal Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pheochromocytoma, Neuroblastoma, Paraganglioma, Medullary Thyroid Carcinoma, Carcinoid Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
123I-meta-iodobenzylguanidine
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Worsley, MD
Phone
604-875-4629
Email
worsley@triumf.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Worsley, MD
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Coastal Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
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