Trial record 2 of 217 for:    "Adrenal Gland Diseases" [DISEASE]

Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gisela Mueller, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721929
First received: July 23, 2008
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.


Condition Intervention
Adrenal Gland Disease
Procedure: MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Diagnosis of either benign or malignant adrenal mass on pathology [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
    definitive diagnosis of adrenal mass


Secondary Outcome Measures:
  • stability of growth of mass on follow up imaging [ Time Frame: 3-24 months ] [ Designated as safety issue: No ]
    evidence for benign or malignant mass based on assessment of stability or growth


Enrollment: 16
Study Start Date: October 2003
Study Completion Date: July 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adrenal mass group Procedure: MRI
Magnetic Resonance Imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients can participate in this study if they are 18 years of age or older and if they have had a Cat Scan (CT scan) performed with and without contrast media (medication given intravenously to enhance the CT images) or if patients are scheduled to have a CT scan performed and if the reason their physician ordered the CT is because they have an adrenal mass of an unknown type.

Exclusion Criteria:

  • Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
  • Pregnant patients or patients who are lactating.
  • A patient who is claustrophobic and would require sedation to complete the MRI exam.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721929

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Gisela Mueller, MD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00721929     History of Changes
Other Study ID Numbers: 2003-0148
Study First Received: July 23, 2008
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
adrenal glands, adrenal masses

Additional relevant MeSH terms:
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014