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