NCT04871139

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

Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Contrast-Enhanced Mammography	Undergo CEM
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Radioactive Iodine	Given IV

Timeline

• Start date: 2021-04-08
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2021-05-04
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study