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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454103
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : August 18, 2010
Information provided by:
University of Wuerzburg

Brief 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.

Condition or disease Intervention/treatment Phase
Adrenal Tumor Adrenocortical Carcinoma Drug: 123I-Iodometomidate Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454103

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Wuerzburg, Germany, D-97080
Sponsors and Collaborators
University of Wuerzburg
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Principal Investigator: Christoph Reiners, MD University of Wuerzburg
Layout table for additonal information Identifier: NCT00454103    
Other Study ID Numbers: Wue_123IMTO_100/05
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: October 2007
Keywords provided by University of Wuerzburg:
adrenocortical carcinoma (ACC)
adrenal tumor
metastastic adrenocortical carcinoma
Additional relevant MeSH terms:
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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