Lipid-poor Adrenal Masses: Evaluation With Chemical Shift... | NCT00721929

Studies
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

NCT00721929

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Dec 6, 2012Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Adrenal Gland Disease

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 23, 2008

First Posted Date

Jul 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 6, 2012Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adrenal mass group	Experimental		Procedure: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Procedure	Magnetic Resonance Imaging	adrenal mass group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of either benign or malignant adrenal mass on pathology	definitive diagnosis of adrenal mass	0-6 months

Secondary Outcomes

Measure	Description	Time Frame
stability of growth of mass on follow up imaging	evidence for benign or malignant mass based on assessment of stability or growth	3-24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D000307	Adrenal Gland Diseases

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided