Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

Adrenocortical Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454103
• Other study ID #: Wue_123IMTO_100/05
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 28, 2007
• Last updated: August 17, 2010
• Start date: March 2007
• Est. completion date: February 2009

Study information

• Verified date: October 2007
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The improvement of conventional imaging techniques has led to an increased detection rate of different adrenal tumors. Since those tumors can belong to a variety of entities the therapeutic consequences also show considerable variation. In order to definitely determine the type of tumor, invasive procedures like CT guided biopsies are often required, which could be avoided by a tumor specific imaging method. The presently available scintigraphic procedures are either time consuming and lead to high radiation exposure or are technically demanding. The steroidogenic enzymes CYP11B1 (11ß-hydroxylase)and CYP11B2 (aldosterone synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable targets for a specific imaging technique. In our project we evaluate 123I-Iodometomidate which binds to both CYP11B enzymes as radiotracer for adrenal scintigraphy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Adrenal tumor seen by CT or MRT-scan with diameter of at least 2 cm or patient with adrenocortical carcinoma and suspected metastasis or local recurrence or patients with primary hyperaldosteronismus and adrenal tumour > 1 cm

2. Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria

3. Age = 30 Jahre

4. Effective contraception (pearl index <1%)

5. Written informed consent

Exclusion Criteria:

1. Pregnancy or breast feeding

2. Renal insufficiency (serum creatinine > 2,0 mg/dl or MDRD < 60 ml/min)

3. Known allergy to etomidate or constituents of the test drug

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Tumor
• Adrenocortical Carcinoma

Intervention

Drug:
• 123I-Iodometomidate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany,