Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Adrenal Tumor Adrenocortical Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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123I-Iodometomidate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No