NCT00721929

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

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

October 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

6.8 years

First QC Date

July 23, 2008

Last Update Submit

December 4, 2012

Conditions

Adrenal Gland Disease

Keywords

adrenal glands, adrenal masses

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of either benign or malignant adrenal mass on pathology

    definitive diagnosis of adrenal mass

    0-6 months

Secondary Outcomes (1)

  • stability of growth of mass on follow up imaging

    3-24 months

Study Arms (1)

adrenal mass group

EXPERIMENTAL
Procedure: MRI

Interventions

MRIPROCEDURE

Magnetic Resonance Imaging

adrenal mass group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Adrenal Gland Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

October 1, 2003

Primary Completion

July 1, 2010

Study Completion

July 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

US(1)