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Breast Cancer Screening with CESM for Women with Dense Breasts

This study, called CMIST, is comparing two types of breast cancer screening for women with dense breasts: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) and digital breast tomosynthesis (DBT). The goal is to see if CESM can find more cancers with fewer false alarms than DBT. You can join if you are a woman between 45 and 74 years old with dense breasts (ACR BI-RADS® categories c or d). The study aims to measure how many cancers are found (Cancer Detection Rate) and how often women are called back for more tests (Recall Rate). The current recruitment status is unclear, but the study plans to enroll 2032 participants.

Study design
This interventional study plans to enroll 2032 women. All participants will receive both DBT and CESM screenings.
What's involved
You would have a standard DBT and CESM screening at the start of the study, and again one year later. You would also have a follow-up contact at two years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after their initial imaging to confirm no interval breast cancer diagnosis.

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NCT05625659

Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts

Recruiting
NAAges 45–74InterventionalDiagnostic
American College of Radiology
~2,032 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cancer Detection Rate
Measured over Year 0
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

13 sites across 11 states
Florida2
Massachusetts2
Alabama1
Michigan1
New Jersey1
New York1
North Carolina1
Pennsylvania1

Who to contact

Christopher Comstock, MD
[email protected]
212-746-6000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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:
3\. Women with known or suspected renal impairment. Requirements for glomerular filtration rate (GFR) determination prior to IV iodinated contrast administration are determined by local site standard practice. Criteria that should be considered include, but are not limited to, the following:
Age \>60 years old
History of renal disease, including dialysis, kidney transplant, single kidney, renal cancer, and renal surgery
History of hypertension requiring medical therapy
History of diabetes mellitus
Use of metformin or metformin-containing drug combinations
4\. Women who are pregnant, breast feeding, or planning to become pregnant from screening until 30 days after the last administration of Omnipaque (iohexol).
5\. Large breasted women that require multiple images per standard view of the breast (Tiling) as determined by their most recent mammogram.

What this trial measures

  • Cancer Detection RateYear 0

    The cancer detection rate (CDR) at the participant level at Year 0. This measure will be evaluated for CESM and DBT

  • Recall Rate1 Year

    The recall rate for participants at Year 1, which will be estimated for each imaging modality separately.