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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01723124
• Other study ID #: 12-004322
• Status: Terminated
• Phase: N/A
• First received: July 24, 2012
• Last updated: September 19, 2016
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: September 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 228
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Molecular Breast Imaging
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of breast cancer detection rate for Year 0 and Year 2.	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.	Year 2 of study	No
Primary	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	No
Secondary	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.	Performed at Year 2 of study	No

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