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Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molecular Breast Imaging
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Dense breast tissue, breast cancer screening, molecular breast imaging, breast cancer, breast

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- 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]

Exclusion Criteria:

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Molecular Breast Imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Molecular Breast Imaging (MBI) scan
The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.

Full Information

First Posted
July 24, 2012
Last Updated
September 19, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01723124
Brief Title
Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up
Official Title
Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Dose specified in protocol was not adequate to achieve optimal resolution.
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Dense breast tissue, breast cancer screening, molecular breast imaging, breast cancer, breast

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Molecular Breast Imaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Molecular Breast Imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Molecular Breast Imaging (MBI) scan
Description
The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.
Time Frame
Performed at Year 0 of study
Secondary Outcome Measure Information:
Title
Molecular Breast Imaging (MBI) scan
Description
The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.
Time Frame
Performed at Year 2 of study
Other Pre-specified Outcome Measures:
Title
Comparison of breast cancer detection rate for Year 0 and Year 2.
Description
The breast cancer detection rate for Year 0 and Year 2 MBI will be compared to each other and to the breast cancer detection rates for the screening mammograms performed in Year 0 and Year 2.
Time Frame
Year 2 of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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] Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Rhodes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21045179
Citation
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.
Results Reference
background
Links:
URL
http://newsblog.mayoclinic.org/2008/09/03/breast-cancer-molecular-breast-imaging-mammography/
Description
Mayo Clinic News
URL
http://www.youtube.com/watch?v=DOQBLe8MdH0
Description
Mayo Clinic You Tube Channel

Learn more about this trial

Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up

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