Comparison of Three Methods for Early Detection of Breast Cancer

Mayo Clinic

Status and phase

Completed

Early Phase 1

Conditions

Proliferative Breast Disease

Treatments

Drug: Lumason

Diagnostic Test: Contrast Enhanced imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT03954015

18-003544

Details and patient eligibility

About

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).

Full description

The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.

Positive predictive value of CEDM in detecting lesions seen on MR
Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.

Enrollment

3 patients

Sex

Female

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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