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

March 28, 2007
August 17, 2010
March 2007
December 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00454103 on ClinicalTrials.gov Archive Site
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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy
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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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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Adrenal Tumor
  • Adrenocortical Carcinoma
Drug: 123I-Iodometomidate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00454103
Wue_123IMTO_100/05
Yes
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University of Wuerzburg
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Principal Investigator: Christoph Reiners, MD University of Wuerzburg
University of Wuerzburg
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP