NCT03954015

Brief Summary

Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

March 5, 2019

Last Update Submit

January 5, 2022

Conditions

Proliferative Breast Disease

Outcome Measures

Primary Outcomes (4)

  • CEUS true positive diagnosis

    The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.

    1 year

  • CEUS false positive diagnosis

    The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram

    1 year

  • CEUS true negative diagnosis

    The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.

    1 year

  • CEUS false negative diagnosis

    The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.

    1 year

Study Arms (1)

patients over age 30 with suspicious BIRADS 4/5 Lesions

OTHER

Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.

Diagnostic Test: Contrast Enhanced imagingDrug: Lumason

Interventions

Contrast Enhanced imagingDIAGNOSTIC_TEST

Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.

Also known as: Lumason
patients over age 30 with suspicious BIRADS 4/5 Lesions
LumasonDRUG

FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.

patients over age 30 with suspicious BIRADS 4/5 Lesions

Eligibility Criteria

Age30 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales greater than 30 years of age
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Patients, greater than 30 years of age
  • In good general health as evidenced by medical history
  • BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.

You may not qualify if:

  • Patients who are less than 30 years of age
  • Have known or suspected cardiac shunts
  • Have history of hypersensitive allergic reactions to any imaging contrast agents
  • Pregnant (a urine pregnancy test will be given at no cost to the patient)
  • Are nursing babies
  • Poor renal function
  • Are unwilling or unable (such as having a pacemaker) to undergo a CEMR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Katrina N. Glazebrook, M.B., Ch.B.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2019

First Posted

May 17, 2019

Study Start

October 15, 2019

Primary Completion

June 30, 2020

Study Completion

October 5, 2021

Last Updated

January 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)