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

NCT05036083 | Completed Results FDA Device

• 2 other identifiers: 2020-1267NCI-2021-08979
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Percentage of Lesions That Appeared Larger on CEM

  One timepoint- at presentation

• Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging

  1 timepoint at presentation

• Rate of Malignancy

  One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection

Other Outcomes (2)

• Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort.

  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.

  Two timepoints- at first CEM imaging presentation and at CEM-guided biopsy (within 2 months)

Study Arms (1)

Diagnostic (CEM, DBT, medical record)

EXPERIMENTAL

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.

Procedure: Contrast-Enhanced Mammography; Procedure: Digital Tomosynthesis Mammography; Other: Electronic Health Record Review; Drug: Iodinated Contrast Agent

Interventions

Contrast-Enhanced Mammography PROCEDURE

Undergo CEM

Also known as: CEM

Diagnostic (CEM, DBT, medical record)

Digital Tomosynthesis Mammography PROCEDURE

Undergo DBT

Also known as: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast

Diagnostic (CEM, DBT, medical record)

Electronic Health Record Review OTHER

Medical records reviewed

Diagnostic (CEM, DBT, medical record)

Iodinated Contrast Agent DRUG

Given IV

Also known as: Iodinated Contrast Dye, Iodine-containing Contrast Media

Diagnostic (CEM, DBT, medical record)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Olena Weaver
• Organization: M.D. Anderson Cancer Center

ooweaver@mdanderson.org

713-471-3613

Study Officials

• Olena Weaver

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: March 19, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-08

Locations

US (1)