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Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00454103
Enrollment
Unknown
Registered
2007-03-30
Start date
2007-03-31
Completion date
2009-02-28
Last updated
2010-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Tumor, Adrenocortical Carcinoma

Keywords

adrenocortical carcinoma (ACC), adrenal tumor, metastastic adrenocortical carcinoma

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.

Interventions

DRUG123I-Iodometomidate

Sponsors

University of Wuerzburg
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026