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Phase 1/Phase 2
30 Years
N/A
Not Enrolling
Both
Adrenal Tumor, Adrenocortical Carcinoma

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Trial Information


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Christoph Reiners, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wuerzburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Wue_123IMTO_100/05

NCT ID:

NCT00454103

Start Date:

March 2007

Completion Date:

February 2009

Related Keywords:

  • Adrenal Tumor
  • Adrenocortical Carcinoma
  • adrenocortical carcinoma (ACC)
  • adrenal tumor
  • metastastic adrenocortical carcinoma
  • Adrenal Gland Neoplasms
  • Carcinoma
  • Adrenocortical Carcinoma

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