NCT01723124

Brief Summary

The purpose of this research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2012

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

Study Start

First participant enrolled

July 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

July 24, 2012

Last Update Submit

September 19, 2016

Conditions

Breast Cancer

Keywords

Dense breast tissuebreast cancer screeningmolecular breast imagingbreast cancerbreast

Outcome Measures

Primary Outcomes (1)

  • Molecular Breast Imaging (MBI) scan

    The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.

    Performed at Year 0 of study

Secondary Outcomes (1)

  • Molecular Breast Imaging (MBI) scan

    Performed at Year 2 of study

Other Outcomes (1)

  • Comparison of breast cancer detection rate for Year 0 and Year 2.

    Year 2 of study

Study Arms (1)

Molecular Breast Imaging

EXPERIMENTAL

Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.

Procedure: Molecular Breast Imaging

Interventions

Molecular Breast ImagingPROCEDURE

Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.

Molecular Breast Imaging

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign \[Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2\]

You may not qualify if:

  • Subjects will be excluded if they:
  • Are unable to understand and sign the consent form
  • Are pregnant or lactating
  • Are physically unable to sit upright and still for 40 minutes
  • Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
  • Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
  • Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention
  • Have undergone bilateral mastectomy
  • Have had a prior MBI within 20 months of scheduled study MBI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.

    PMID: 21045179BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Deborah Rhodes, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 24, 2012

First Posted

November 7, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)