NCT03031561

Brief Summary

This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

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

March 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

3.2 years

First QC Date

January 20, 2017

Last Update Submit

May 14, 2025

Conditions

Breast CarcinomaMicrocalcification

Outcome Measures

Primary Outcomes (2)

  • Number of microcalcifications seen on MicroPure ultrasound

    The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.

    Baseline

  • Number of microcalcifications seen on grayscale ultrasound

    The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.

    Baseline

Secondary Outcomes (1)

  • Number of microcalcifications determined by pathology findings

    Baseline

Study Arms (1)

Diagnostic (standard ultrasound, MicroPure, biopsy)

EXPERIMENTAL

Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.

Device: UltrasoundDevice: MicoPure ultrasoundProcedure: Biopsy of Breast

Interventions

UltrasoundDEVICE

Undergo standard ultrasound

Also known as: Ultrasound Imaging, US
Diagnostic (standard ultrasound, MicroPure, biopsy)
MicoPure ultrasoundDEVICE

Undergo MicoPure ultrasound

Diagnostic (standard ultrasound, MicroPure, biopsy)
Biopsy of BreastPROCEDURE

Undergo breast biopsy or surgical resection

Also known as: Breast Biopsy
Diagnostic (standard ultrasound, MicroPure, biopsy)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Give written informed consent
  • Be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical excision for the evaluation of a breast lesion or abnormality containing microcalcifications seen on mammography

You may not qualify if:

  • Is clinically unstable, severely ill, or moribund

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCalcinosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Flemming Forsberg, PhD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 25, 2017

Study Start

March 1, 2012

Primary Completion

April 30, 2015

Study Completion

March 10, 2016

Last Updated

May 15, 2025

Record last verified: 2025-05