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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036083
• Other study ID #: 2020-1267
• Secondary ID: NCI-2021-0897920
• Status: Completed
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: March 25, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Invasive Breast Carcinoma

Intervention

Procedure:
• Contrast-Enhanced Mammography
Undergo CEM
• Digital Tomosynthesis Mammography
Undergo DBT

Other:
• Electronic Health Record Review
Medical records reviewed

Drug:
• Iodinated Contrast Agent
Given IV

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of contrast enhanced mammography (CEM) for incremental cancer detection in the ipsilateral and contralateral breasts	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.	Up to 12 months

External Links

•   M D Anderson Cancer Center