Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
Eligible age
45–74 yrs
Accepts
Women
Locations
9 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
The over-arching goal of the Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST) is to determine if dual-energy contrast-enhanced spectral mammography (CESM) can detect more cancers with fewer false positives than digital breast tomosynthesis (DBT) in women with dense breasts. Aim 1: To evaluate the performance of CESM compared to DBT at baseline for breast-cancer screening in women with dense breasts. Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts.
Sponsor: American College of Radiology
You may qualify if…
- ✓ 1\. Women must have mammographically dense breasts, ACR BI-RADS® lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most recent prior screening.
- ✓ 2\. Women agree to not undergo whole breast screening ultrasound for the duration of the trial until the year 2 standard of care imaging.
- ✓ 3\. Women must not have symptoms or signs of benign or malignant breast disease (e.g., bloody, or clear nipple discharge, breast lump, focal breast pain).
- ✓ 4\. Women must be able to undergo intravenous (IV) administration of iodinated contrast (e.g., no contraindication to intravenous contrast administration for Omnipaque \[iohexol\], and no known allergy-like reaction to iodine or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology \[ACR\]: https://www.acr.org/-/media/ACR/files/clinical-resources/contrast\_media.pdf).
- ✓ 5\. Women must not be pregnant or breast-feeding. All females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and CESM must have a negative blood test or urine pregnancy test prior to Omnipaque (iohexol) administration. A female of childbearing potential is any woman, regardless of sexual orientation, sexual identity or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- ✓ 6\. Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the Year 1 DBT and CESM studies are performed.
You may not qualify if…
- ✕ 1\. Women currently undergoing treatment for breast cancer, or planning surgery for a high-risk lesion (ADH, ALH, LCIS, papilloma, radial scar).
- ✕ 2\. Women who have had the following are not eligible:
- ✕ 1. a mammogram less than 11 months prior to study entry.
- ✕ 2. screening breast ultrasound within 11 months prior to study entry.
- ✕ 3. breast MRI less than 36 months prior to study entry.
- ✕ 4. contrast-enhanced spectral mammography less than 36 months prior to study entry.
- ✕ 5. molecular breast imaging (MBI) less than 36 months prior to study entry.
- ✕ 6. breast prosthetic implants (silicone or saline).
Where it's recruiting
Birmingham
Boca Raton · The Villages
Wellesley Hills
Detroit
New York
Greenville
Philadelphia
Houston
Charlottesville
Source: ClinicalTrials.gov · NCT05625659 · last updated 2026-02-19