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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

This study has been completed.
Information provided by:
University of Wuerzburg Identifier:
First received: March 28, 2007
Last updated: August 17, 2010
Last verified: October 2007
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.

Condition Intervention Phase
Adrenal Tumor Adrenocortical Carcinoma Drug: 123I-Iodometomidate Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by University of Wuerzburg:

Study Start Date: March 2007
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00454103

Wuerzburg, Germany, D-97080
Sponsors and Collaborators
University of Wuerzburg
Principal Investigator: Christoph Reiners, MD University of Wuerzburg
  More Information Identifier: NCT00454103     History of Changes
Other Study ID Numbers: Wue_123IMTO_100/05
Study First Received: March 28, 2007
Last Updated: August 17, 2010

Keywords provided by University of Wuerzburg:
adrenocortical carcinoma (ACC)
adrenal tumor
metastastic adrenocortical carcinoma

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Adrenal Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenal Cortex Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on September 21, 2017