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123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
Conditions
Pheochromocytoma - Neuroblastoma - Paraganglioma - Medullary Thyroid Carcinoma - Carcinoid Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neuroblastoma - Neuroendocrine Tumors - Paraganglioma - Pheochromocytoma - Thyroid Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Primary Purpose: Diagnostic
Intervention
Name: 123I-meta-iodobenzylguanidine
Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.
- 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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.
Location
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Status:
Sponsors
Vancouver Coastal Health
Source
Vancouver Coastal Health
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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