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.

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

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 & 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 CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.	One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection	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

Secondary Outcome Measures

Name	Time	Method
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.	At presentation, Day 1	Fraction of malignant lesions detected by each component of CEM
Percentage of Lesions That Appeared Larger on CEM	One timepoint- at presentation	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.
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging	1 timepoint at presentation	Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation
Rate of Malignancy	One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection	Rate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy