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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Vancouver Coastal Health.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373736
First Posted: June 15, 2011
Last Update Posted: June 15, 2011
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.
Information provided by:
Vancouver Coastal Health
  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:


Further study details as provided by Vancouver Coastal Health:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Daniel Worsley, Vancouver Coastal Health
ClinicalTrials.gov Identifier: NCT01373736     History of Changes
Other Study ID Numbers: H10-02695
First Submitted: June 13, 2011
First Posted: June 15, 2011
Last Update Posted: June 15, 2011
Last Verified: June 2011

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