NCT00943241

Brief Summary

To expand the understanding of the uptake and distribution of Tc-99m sestamibi in the breast in a normal female population undergoing myocardial perfusion imaging using Molecular Breast Imaging (MBI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

July 20, 2009

Last Update Submit

February 12, 2013

Conditions

Breast Cancer

Keywords

BreastBreast CancerMBIMolecular Breast ImagingMolecular Imaging

Outcome Measures

Primary Outcomes (1)

  • Biopsy-proven breast cancer

    12 months

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female subjects who are undergoing Myocardial Perfusion imaging in the Nuclear Cardiology laboratory at the Mayo Clinic in Rochester, MN.

You may qualify if:

  • They have had a mammogram at Mayo Clinic Rochester within the last 12 months
  • Undergoing myocardial perfusion imaging

You may not qualify if:

  • They are unable to understand and sign the consent form
  • They are physically unable to sit upright and still for 20 minutes
  • They have undergone breast surgery or breast biopsy within the last 12 months.
  • They have had trauma to the breast tissue or undergone radiation treatment to the breast within the last 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Deborah J. Rhodes, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

US(1)