The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts

Breast Cancer Clinical Trial

Official title:

The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667532
• Other study ID #: 2022-0651
• Secondary ID: NCI-2022-10200
• Status: Recruiting
• Start date: December 5, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Olena Weaver, MD
• Phone: (713) 745-4555
• Email: ooweaver[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts

Description:

Primary Objectives:

• To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography.

• To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584.

Secondary Objectives:

• To perform within-subject comparison of the cancer detection rate between CEM and FFDM.

• To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts.

• To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT.

• In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT.

Exploratory Objectives:

• To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk.

• To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts.

• To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites

2. Willingness to co-enroll or currently enrolled in PA17-0584

3. Willingness to participate in the study and ability to provide informed consent

Exclusion Criteria:

1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.

2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding

3. Personal history of breast cancer (DCIS or invasive breast cancer)

4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer

5. Breast biopsy within 6 months

6. Breast surgery within 12 months

7. Breast MRI, MBI, or CEM performed within 24 months

8. Known allergy to iodine-containing contrast agents

9. History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast

10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Contrast Enhanced Mammography
Screening Modality

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	To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography		through study completion; an average of 1 year.

External Links

•   M D Anderson Cancer Center