An Imaging Technology, Contrast-Enhanced Mammography, in Predicting Breast Cancer

NCT ID: NCT04871139

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2026-03-01

Brief Summary

This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the added value of contrast enhancement of contrast-enhanced mammography (CEM) compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with suspicious mammographic architectural distortion (MAD)s.

SECONDARY OBJECTIVES:

I. To compare sensitivity, specificity, negative predictive value and positive predictive value of CEM versus FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS in patients with suspicious MADs.

II. To evaluate whether the presence of enhancement on CEM correlates with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy.

III. To estimate the proportion of cases in which CEM changes the original target for a stereotactic biopsy.

IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM findings.

EXPLORATORY OBJECTIVES:

I. To evaluate the correlation of blood biomarkers and the presence of invasive cancer and DCIS on pathology in the study patients.

II. To evaluate the role of CEM enhancement pattern in choosing a precise target for a stereotactic biopsy.

III. To develop an objective method of quantifying the degree of enhancement above background using AI-based digital image analysis.

IV. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious MADs.

V. In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to DCIS or invasive cancer for those patients who will require surgery as a part of their routine clinical care.

VI. To compare the performance of FFDM (obtained as a part of the recent prior screening or diagnostic mammographic work-up) and LE CEM images (obtained as a part of the CEM study) in terms of accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the detection of invasive cancer and high-grade DCIS.

OUTLINE:

Patients receive iodine-based contrast agent intravenously (IV) and the undergo CEM over 10-15 minutes.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (iodine-based contrast, CEM)

Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Contrast-Enhanced Mammography

Intervention Type: PROCEDURE

Undergo CEM

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Radioactive Iodine

Intervention Type: OTHER

Given IV

Interventions

Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Contrast-Enhanced Mammography

Undergo CEM

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Radioactive Iodine

Given IV

Intervention Type: OTHER

Other Intervention Names

BIOPSY_TYPE; Bx; CEM

Eligibility Criteria

Inclusion Criteria

• Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC
• Age 25-85 years
• Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent

Exclusion Criteria

• Reported history of an allergic reaction to iodinated contrast
• History of anaphylactic reaction to any substance
• Renal insufficiency
• Pregnancy or lactation within 6 months
• Breast surgery affecting the site of interest within prior 6 months
• Breast biopsy at the site of interest within the last 2 months

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olena Weaver

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Olena Weaver

Role: primary

ooweaver@mdanderson.org

713-471-3613

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-03404

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-0031

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0031

Identifier Type: -

Identifier Source: org_study_id