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123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01373736
Recruitment Status : Unknown
Verified June 2011 by Vancouver Coastal Health.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2011
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:

June 13, 2011
June 15, 2011
June 15, 2011
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No Changes Posted
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123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
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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.
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Interventional
Phase 3
Primary Purpose: Diagnostic
  • Pheochromocytoma
  • Neuroblastoma
  • Paraganglioma
  • Medullary Thyroid Carcinoma
  • Carcinoid Tumors
Drug: 123I-meta-iodobenzylguanidine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01373736
H10-02695
Yes
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Daniel Worsley, Vancouver Coastal Health
Vancouver Coastal Health
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Principal Investigator: Daniel Worsley, MD Vancouver Coastal Health
Vancouver Coastal Health
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP