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

Not Applicable

Completed

• Conditions: Breast Carcinoma; Invasive Breast Carcinoma
• Interventions: Procedure: Contrast-Enhanced Mammography; Procedure: Digital Tomosynthesis Mammography; Other: Electronic Health Record Review; Drug: Iodinated Contrast Agent

• Registration Number: NCT05036083
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2021-03-19
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Status Verified: 2024-03
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CEM, DBT, medical record)	Electronic Health Record Review	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.
Diagnostic (CEM, DBT, medical record)	Iodinated Contrast Agent	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.
Diagnostic (CEM, DBT, medical record)	Contrast-Enhanced Mammography	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.
Diagnostic (CEM, DBT, medical record)	Digital Tomosynthesis Mammography	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of contrast enhanced mammography (CEM) for incremental cancer detection in the ipsilateral and contralateral breasts	Up to 12 months	Defined as the number of concordant cases between CEM/low energy (LE) and pathologic evaluation divided by the total sample size. Will be estimated along with 95% confidence intervals; and compared between the modalities using the McNemar test or the weighted generalized score statistic proposed by Kosinski, if deemed appropriate. To account for multiple lesions, outcome variables will be analyzed using generalized liner mix models or extended McNemar's test, and additional analyses may be further performed if deemed appropriate.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States