Testing New Method of Analyzing MR Images | NCT00630318

Studies
Testing New Method of Analyzing MR Images

NCT00630318

Sponsor

Indiana University

Status

Terminated

Last Update Posted

Jan 12, 2017Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Breast Abnormalities

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to accrue enough subjects to analyze data.

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Feb 28, 2008

First Submission Date that Met QC Criteria

Mar 6, 2008

First Posted Date

Mar 7, 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

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.

Detailed Description

The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes.

The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results.

The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	15-20 minutes MR imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy.		After analysis of images

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females
Age 18 years or greater
Undergoing breast MRI exam

Exclusion Criteria:

Pregnancy
Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia)
History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality

Accepts Healthy Volunteers

Sex

Female

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

Name	Affiliation	Role
Susan E. Clare, MD, Ph.D.	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Hospital		Indianapolis	Indiana	46202	United States