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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723124

Enrollment

228

Registered

2012-11-07

Start date

2012-07-31

Completion date

2014-05-31

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Dense breast tissue, breast cancer screening, molecular breast imaging, breast cancer, breast

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.

Interventions

PROCEDUREMolecular 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Molecular Breast Imaging (MBI) scan	Performed at Year 0 of study	The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.

Secondary

Measure	Time frame	Description
Molecular Breast Imaging (MBI) scan	Performed at Year 2 of study	The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.

Other

Measure	Time frame	Description
Comparison of breast cancer detection rate for Year 0 and Year 2.	Year 2 of study	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026