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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

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ClinicalTrials.gov Identifier: NCT00454103
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : August 18, 2010
Sponsor:
Information provided by:
University of Wuerzburg

Study Description
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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

Study Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454103


Locations
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Germany
Wuerzburg, Germany, D-97080
Sponsors and Collaborators
University of Wuerzburg
Investigators
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Principal Investigator: Christoph Reiners, MD University of Wuerzburg
More Information
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ClinicalTrials.gov Identifier: NCT00454103     History of Changes
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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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