Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

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Brief Title

Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy


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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional




Condition

Adrenal Tumor

Intervention

123I-Iodometomidate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

March 2007

Completion Date

February 2009

Primary Completion Date

December 2008

Eligibility 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 [email protected] (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
      

Gender

All

Ages

30 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christoph Reiners, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00454103

Organization ID

Wue_123IMTO_100/05



Study Sponsor

University of Wuerzburg


Study Sponsor

Christoph Reiners, MD, Principal Investigator, University of Wuerzburg


Verification Date

October 2007