Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

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.

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Key information

Conditions

Adrenal Tumor Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Würzburg, D-97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria
Age ≥ 30 Jahre
Effective contraception (pearl index <1%)
Written informed consent

Exclusion criteria

Pregnancy or breast feeding
Renal insufficiency (serum creatinine > 2,0 mg/dl or MDRD < 60 ml/min)
Known allergy to etomidate or constituents of the test drug

Treatment and study plan

123I-Iodometomidate

Drug

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Mar 30, 2007
Registry last updated: Aug 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed