NCT00630318

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 28, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

February 28, 2008

Last Update Submit

January 11, 2017

Conditions

Keywords

MR scanning

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MRIDEVICE

15-20 minutes MR imaging

Eligibility Criteria

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

You may qualify if:

  • Females
  • Age 18 years or greater
  • Undergoing breast MRI exam

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

  • Susan E. Clare, MD, Ph.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations