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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

Primary Purpose

Adrenal Tumor, Adrenocortical Carcinoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
123I-Iodometomidate
Sponsored by
University of Wuerzburg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenal Tumor focused on measuring adrenocortical carcinoma (ACC), adrenal tumor, metastastic adrenocortical carcinoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 28, 2007
Last Updated
August 17, 2010
Sponsor
University of Wuerzburg
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1. Study Identification

Unique Protocol Identification Number
NCT00454103
Brief Title
Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Wuerzburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Tumor, Adrenocortical Carcinoma
Keywords
adrenocortical carcinoma (ACC), adrenal tumor, metastastic adrenocortical carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
123I-Iodometomidate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Hormonal work up of of the adrenal tumor according to ENS@T (European network for the study of adrenal tumours)-criteria Age ≥ 30 Jahre Effective contraception (pearl index <1%) Written informed consent Exclusion Criteria: Pregnancy or breast feeding Renal insufficiency (serum creatinine > 2,0 mg/dl or MDRD < 60 ml/min) Known allergy to etomidate or constituents of the test drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Reiners, MD
Organizational Affiliation
University of Wuerzburg
Official's Role
Principal Investigator
Facility Information:
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany

12. IPD Sharing Statement

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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

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