Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Vancouver Coastal Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Vancouver Coastal Health
ClinicalTrials.gov Identifier:
NCT01373736
First received: June 13, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

June 13, 2011
June 13, 2011
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
Not Provided

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.

Not Provided
Interventional
Phase 3
Primary Purpose: Diagnostic
  • Pheochromocytoma
  • Neuroblastoma
  • Paraganglioma
  • Medullary Thyroid Carcinoma
  • Carcinoid Tumors
Drug: 123I-meta-iodobenzylguanidine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
Not Provided
Not Provided

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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.
Both
Not Provided
No
Contact: Daniel Worsley, MD 604-875-4629 worsley@triumf.ca
Canada
 
NCT01373736
H10-02695
Yes
Daniel Worsley, Vancouver Coastal Health
Vancouver Coastal Health
Not Provided
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