Actively Recruiting
Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
Led by American College of Radiology · Updated on 2026-02-19
2032
Participants Needed
11
Research Sites
227 weeks
Total Duration
On this page
Sponsors
A
American College of Radiology
Lead Sponsor
G
GE Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
-
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:
- a mammogram less than 11 months prior to study entry.
- screening breast ultrasound within 11 months prior to study entry.
- breast MRI less than 36 months prior to study entry.
- contrast-enhanced spectral mammography less than 36 months prior to study entry.
- molecular breast imaging (MBI) less than 36 months prior to study entry.
- breast prosthetic implants (silicone or saline).
- suspected of being at high-risk for breast cancer, as defined by the ACS breast MR screening recommendations (lifetime risk of ≥20%-25%) unless they are unable to undergo an MRI. (Reference Appendix I)
- a history of sickle cell disease.
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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
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History of diabetes mellitus
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Use of metformin or metformin-containing drug combinations
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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.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute
Boca Raton, Florida, United States, 33486
Actively Recruiting
3
Lake Medical Imaging
The Villages, Florida, United States, 32159
Active, Not Recruiting
4
Boston Breast Diagnostic Center
Wellesley Hills, Massachusetts, United States, 02481
Actively Recruiting
5
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Carolina Breast Imaging Specialists
Greenville, North Carolina, United States, 27834
Actively Recruiting
8
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
9
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
University of Virginia
Charlottesville, Virginia, United States, 22911
Actively Recruiting
11
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Actively Recruiting
Research Team
C
Christopher Comstock, MD
CONTACT
E
Etta Pisano, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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