NCT00454103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 18, 2010

Status Verified

October 1, 2007

Enrollment Period

1.8 years

First QC Date

March 28, 2007

Last Update Submit

August 17, 2010

Conditions

Adrenal TumorAdrenocortical Carcinoma

Keywords

adrenocortical carcinoma (ACC)adrenal tumormetastastic adrenocortical carcinoma

Interventions

123I-IodometomidateDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Würzburg, D-97080, Germany

Location

MeSH Terms

Conditions

Adrenal Gland NeoplasmsAdrenocortical Carcinoma

Interventions

iodophenyl metomidate

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdrenal Cortex NeoplasmsAdrenal Cortex Diseases

Study Officials

  • Christoph Reiners, MD

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 30, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

August 18, 2010

Record last verified: 2007-10

Locations

DE(1)