Recruiting

Contrast-enhanced Mammography

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05667532

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Contrast Enhanced Mammography

Study Details

Brief 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

Conditions

Breast Cancer

Study ID

NCT05667532

Start date

Dec 5, 2022

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Contrast Enhanced Mammography

Interventions

Contrast Enhanced Mammography

Screening Modality

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Olena Weaver, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-16.