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

Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Invasive Breast Carcinoma
• Intervention / Treatment: Other: Electronic Health Record Review; Procedure: Contrast-Enhanced Mammography; Procedure: Digital Tomosynthesis Mammography; Drug: Iodinated Contrast Agent

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Electronic Health Record Review; Medical records reviewed; Procedure: Contrast-Enhanced Mammography; Undergo CEM; Other Names: CEM; Procedure: Digital Tomosynthesis Mammography; Undergo DBT; Other Names: DBT; Digital Breast Tomosynthesis; Digital Tomosynthesis of the Breast; Drug: Iodinated Contrast Agent; Given IV; Other Names: Iodinated Contrast Dye; Iodine-containing Contrast Media

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.	Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation) *Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested	One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth.	Fraction of malignant lesions detected by each component of CEM	At presentation, Day 1
Percentage of Lesions That Appeared Larger on CEM	Largest measurements in imaging were compared to the largest measurements in pathology and the size difference of 5mm or more was considered significant. Fraction of patients in whom CEM detected an increase in lesion size of 5 mm or more was reported and analyzed.	One timepoint- at presentation
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging	Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation	1 timepoint at presentation
Rate of Malignancy	Rate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy	One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort.	Percentage of patients who underwent both CEM and MRI	One timepoint for CEM data (at presentation) +/- 2 month (4 month total) for MRI
The Fraction of CEM Biopsies That Achieve Adequate Sampling of the Target.	Patients who required a CEM-guided biopsy and successfully underwent it with adequate tissue sampling. Percentage of all non-index CEM lesions that required a CEM biopsy.	Two timepoints- at first CEM imaging presentation and at CEM-guided biopsy (within 2 months)

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Olena Weaver, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-1267 (Other Identifier: M D Anderson Cancer Center); NCI-2021-08979 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes