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NCT01373736 Clinical Trial

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

Neuroblastoma Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01373736
Other study ID # H10-02695
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received June 13, 2011
Last updated June 13, 2011

Study information
Verified date June 2011
Source Vancouver Coastal Health
Contact Daniel Worsley, MD
Phone 604-875-4629
Email worsley@triumf.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 3.0 mg/dL [265 µmol/L]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;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.

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• 123I-meta-iodobenzylguanidine

Locations
Country Name City State
Canada Vancouver Coastal Health Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

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