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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy
This study is currently recruiting participants.
Verified by University of Wuerzburg, October 2007
First Received: March 28, 2007   Last Updated: October 9, 2007   History of Changes
Sponsored by: University of Wuerzburg
Information provided by: University of Wuerzburg
ClinicalTrials.gov Identifier: NCT00454103
  Purpose

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 Intervention Phase
Adrenal Tumor
Adrenocortical Carcinoma
Drug: 123I-Iodometomidate
Phase I
Phase II

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

Study Start Date: March 2007
Estimated Study Completion Date: April 2009
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454103

Contacts
Contact: Stefanie Hahner, MD 0049 931 201 1 hahner_s@medizin.uni-wuerzburg.de
Contact: Andreas Schirbel, PhD 0049 9331 201 35879 schirbel_a@klinik.uni-wuerzburg.de

Locations
Germany
Recruiting
Wuerzburg, Germany, D-97080
Contact: Stefanie Hahner, MD     0049 931 201 1     hahner_s@medizin.uni-wuerzburg.de    
Contact: Andreas Schirbel, PhD     0049 931 201 35879     schirbel_a@klinik.uni-wuerzburg.de    
Principal Investigator: Stefanie Hahner, MD            
Principal Investigator: Andreas Schirbel, PhD            
Principal Investigator: Bruno Allolio, MD            
Sub-Investigator: Michael Kreissl, MD            
Sponsors and Collaborators
University of Wuerzburg
Investigators
Principal Investigator: Christoph Reiners, MD University of Wuerzburg
  More Information

No publications provided

Study ID Numbers: Wue_123IMTO_100/05
Study First Received: March 28, 2007
Last Updated: October 9, 2007
ClinicalTrials.gov Identifier: NCT00454103     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:
adrenocortical carcinoma (ACC)
adrenal tumor
metastastic adrenocortical carcinoma

Study placed in the following topic categories:
Adrenal Gland Neoplasms
Adrenocortical Carcinoma
Endocrine System Diseases
Adrenal Gland Diseases
Endocrinopathy
Adrenal Cortex Neoplasms
Epinephrine
Adrenal Cortex Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Adrenocortical Carcinoma
Adrenal Gland Diseases
Endocrine System Diseases
Carcinoma
Neoplasms
Adrenal Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Neoplasms
Adenocarcinoma
Adrenal Cortex Diseases
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009