Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

This study has been completed.

Sponsor:

Information provided by:

University of Wuerzburg

ClinicalTrials.gov Identifier:

NCT00454103

First received: March 28, 2007

Last updated: August 17, 2010

Last verified: October 2007

History of Changes

Purpose

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:

MedlinePlus related topics: Adrenal Gland Cancer

Genetic and Rare Diseases Information Center resources: Adrenocortical Carcinoma

U.S. FDA Resources

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)

Eligibility


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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454103

Locations


Germany

Wuerzburg, Germany, D-97080

Sponsors and Collaborators

University of Wuerzburg

Investigators


Principal Investigator:	Christoph Reiners, MD	University of Wuerzburg

More Information


ClinicalTrials.gov 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:


Carcinoma Adrenocortical Carcinoma Adrenal Gland Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Adrenal Cortex Neoplasms Endocrine Gland Neoplasms Neoplasms by Site	Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases Etomidate Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics

ClinicalTrials.gov processed this record on September 21, 2017

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