Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy
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ClinicalTrials.gov Identifier: NCT00454103 |
Recruitment Status :
Completed
First Posted : March 30, 2007
Last Update Posted : August 18, 2010
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Condition or disease | Intervention/treatment | Phase |
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Adrenal Tumor Adrenocortical Carcinoma | Drug: 123I-Iodometomidate | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | February 2009 |


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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454103
Germany | |
Wuerzburg, Germany, D-97080 |
Principal Investigator: | Christoph Reiners, MD | University of Wuerzburg |
ClinicalTrials.gov Identifier: | NCT00454103 |
Other Study ID Numbers: |
Wue_123IMTO_100/05 |
First Posted: | March 30, 2007 Key Record Dates |
Last Update Posted: | August 18, 2010 |
Last Verified: | October 2007 |
adrenocortical carcinoma (ACC) adrenal tumor metastastic adrenocortical carcinoma |
Carcinoma Adrenocortical Carcinoma Adrenal Gland Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Adrenal Cortex Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases |