Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion

NCT ID: NCT05036083

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2024-03-25

Brief Summary

This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.

SECONDARY OBJECTIVES:

I. To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.

II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.

III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis.

EXPLORATORY OBJECTIVES:

I. To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort.

II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US.

III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions.

OUTLINE:

Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.

After completion of study treatment, patients are followed up for 12 months.

Conditions

Breast Carcinoma; Invasive Breast Carcinoma

Study Design

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

Study Groups

Diagnostic (CEM, DBT, medical record)

Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.

Group Type: EXPERIMENTAL

Contrast-Enhanced Mammography

Intervention Type: PROCEDURE

Undergo CEM

Digital Tomosynthesis Mammography

Intervention Type: PROCEDURE

Undergo DBT

Electronic Health Record Review

Intervention Type: OTHER

Medical records reviewed

Iodinated Contrast Agent

Intervention Type: DRUG

Given IV

Interventions

Contrast-Enhanced Mammography

Undergo CEM

Intervention Type: PROCEDURE

Digital Tomosynthesis Mammography

Undergo DBT

Intervention Type: PROCEDURE

Electronic Health Record Review

Medical records reviewed

Intervention Type: OTHER

Iodinated Contrast Agent

Given IV

Intervention Type: DRUG

Other Intervention Names

CEM; DBT; Digital Breast Tomosynthesis; Digital Tomosynthesis of the Breast; Iodinated Contrast Dye; Iodine-containing Contrast Media

Eligibility Criteria

Inclusion Criteria

• Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging
• Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC)
• Willingness to participate in the study and ability to provide informed consent

Exclusion Criteria

• Breast surgery within 6 months
• Known allergy to iodine-containing contrast agents
• History of anaphylactic reaction to any substance that required hospitalization or IV placement
• Renal insufficiency; hyperthyroidism
• Detection of non-breast primary or metastatic cancer in the breast

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-08979

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-1267

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1267

Identifier Type: -

Identifier Source: org_study_id