- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00454103
Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy
August 17, 2010 updated by: University of Wuerzburg
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Wuerzburg, Germany, D-97080
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christoph Reiners, MD, University of Wuerzburg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (ACTUAL)
December 1, 2008
Study Completion (ACTUAL)
February 1, 2009
Study Registration Dates
First Submitted
March 28, 2007
First Submitted That Met QC Criteria
March 28, 2007
First Posted (ESTIMATE)
March 30, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 18, 2010
Last Update Submitted That Met QC Criteria
August 17, 2010
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wue_123IMTO_100/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adrenocortical Carcinoma
-
National Cancer Institute (NCI)TerminatedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
-
Dartmouth-Hitchcock Medical CenterM.D. Anderson Cancer Center; Dana-Farber Cancer Institute; AstraZeneca; Kentuckiana...CompletedNonresectable Adrenocortical CarcinomaUnited States
-
Latin American Cooperative Oncology GroupNot yet recruitingCarcinoma Adrenal | Carcinoma, Adrenocortical RecurrentBrazil
-
Memorial Sloan Kettering Cancer CenterRecruitingAdrenocortical Carcinoma | ACC | Metastatic Adrenocortical CarcinomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedAdrenocortical Carcinoma
-
Burzynski Research InstituteTerminatedStage IV Adrenocortical CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdrenal Cortex NeoplasmsUnited States
-
National Cancer Institute (NCI)RecruitingNeuroendocrine Tumors | Carcinoma, Neuroendocrine | Neuroendocrine Carcinomas | Carcinoma, Adrenal Cortical | Carcinoma, AdrenocorticalUnited States
-
University Medical Center GroningenRadboud University Medical Center; Maastricht University Medical Center; UMC... and other collaboratorsRecruitingAdrenocortical Carcinoma | Adrenal IncidentalomaNetherlands
Clinical Trials on 123I-Iodometomidate
-
Wuerzburg University HospitalAssistance Publique - Hôpitaux de Paris; Charite University, Berlin, Germany; Hannover Medical School and other collaboratorsUnknownAdrenal Gland NeoplasmsGermany
-
Institute for Neurodegenerative DisordersTerminatedMultiple Sclerosis | Parkinson Disease | Alzheimer Disease | Healthy ControlsUnited States
-
Institute for Neurodegenerative DisordersTerminatedAlzheimer DiseaseUnited States
-
Institute for Neurodegenerative DisordersUnited States Department of Defense; Molecular NeuroImagingActive, not recruitingParkinson DiseaseUnited States
-
Molecular NeuroImagingTerminatedAlzheimer DiseaseUnited States
-
GE HealthcarePPDCompletedEssential Tremor | Multiple System Atrophy (MSA) | Parkinsonian Syndrome | Parkinson Disease(PD) | Progressive Supranuclear Palsy (PSP)China
-
Institute for Neurodegenerative DisordersIndiana University; Albany Medical CollegeCompletedParkinsonian SyndromeUnited States
-
University of Lausanne HospitalsCompleted
-
Institute for Neurodegenerative DisordersCompleted
-
Molecular NeuroImagingInstitute for Neurodegenerative DisordersCompleted