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

NCT01373736 | Unknown Phase 3 DMC

• 1 other identifier: H10-02695
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pheochromocytoma; Neuroblastoma; Paraganglioma; Medullary Thyroid Carcinoma; Carcinoid Tumors

Interventions

123I-meta-iodobenzylguanidine DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 3.0 mg/dL \[265 µmol/L\]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.

Sponsors & Collaborators

• Vancouver Coastal Health: lead

Study Sites (1)

Vancouver Coastal Health

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Pheochromocytoma; Neuroblastoma; Paraganglioma; Carcinoma, Medullary; Carcinoid Tumor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Daniel Worsley, MD

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Worsley, MD

CONTACT

604-875-4629; worsley@triumf.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Last Updated: June 15, 2011

Record last verified: 2011-06

Locations

CA (1)