NCT00890994

Brief Summary

In this research study, the investigators are testing a new type of breast camera, called Molecular Breast Imaging, to see if it can find tumors in the subject's breast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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

January 19, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

5.8 years

First QC Date

April 29, 2009

Last Update Submit

March 21, 2017

Conditions

Breast Cancer

Keywords

MBIMolecular Breast ImagingBreast CancerDCISBreastCalcificationsMicrocalcifications

Study Arms (1)

Suspected breast cancer

Eligibility Criteria

Age25 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective patients will be identified by the radiologist based on findings in their mammographic, ultrasound or MRI studies. Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study.

You may qualify if:

  • Women with a breast lesion suspicious for DCIS who are scheduled for a stereotactic breast biopsy.
  • Lesion must be considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5).
  • Women between 25 and 90 years of age.

You may not qualify if:

  • Unable to understand or sign a consent form.
  • Pregnant or lactating.
  • Physically unable to sit upright and still for 30-40 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCalcinosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dietlind L. Wahner-Roedler, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 29, 2009

First Posted

April 30, 2009

Study Start

January 19, 2009

Primary Completion

November 14, 2014

Study Completion

November 14, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)