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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 20, 2014