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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
  Purpose

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.


Condition Intervention Phase
Pheochromocytoma
Neuroblastoma
Paraganglioma
Medullary Thyroid Carcinoma
Carcinoid Tumors
 Drug: 123I-meta-iodobenzylguanidine
 Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vancouver Coastal Health:

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373736

Contacts
Contact: Daniel Worsley, MD 604-875-4629 worsley@triumf.ca

Locations
Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z1M9
Sponsors and Collaborators
Vancouver Coastal Health
Investigators
Principal Investigator: Daniel Worsley, MD Vancouver Coastal Health
  More Information

No publications provided

Responsible Party: Daniel Worsley, Vancouver Coastal Health
ClinicalTrials.gov Identifier: NCT01373736     History of Changes
Other Study ID Numbers: H10-02695
Study First Received: June 13, 2011
Last Updated: June 13, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma
Thyroid Neoplasms
Neuroblastoma
Paraganglioma
Pheochromocytoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013