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

NCT05625659 | Recruiting DMC

• 1 other identifier: ACR A4707
• Study Type: interventional
• Target: 2,032
• Locations: 2 countries
• Sites: 11

Brief Summary

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

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Cancer Detection Rate

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

  Year 0

• Recall Rate

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

  1 Year

Study Arms (1)

DBT and CESM Diagnostic Imaging in Women with Dense Breasts

OTHER

Interventional Diagnostic

Diagnostic Test: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)

Interventions

Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) DIAGNOSTIC_TEST

In addition to their standard, digital breast tomosynthesis mammogram (DBT) performed at their regular screening visits, all participants will also receive a contrast-enhanced spectral mammography (CESM). These same diagnostic tests, both the DBT and CESM, with be repeated at 1 year post study entry for all participants. At year 2 post study entry, all participants will return to their usual breast screening exams and no longer received a CESM.

DBT and CESM Diagnostic Imaging in Women with Dense Breasts

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Women agree to not undergo whole breast screening ultrasound for the duration of the trial until the year 2 standard of care imaging.
• \. 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).
• \. 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).
• \. 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).
• \. 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:

• \. Women currently undergoing treatment for breast cancer, or planning surgery for a high-risk lesion (ADH, ALH, LCIS, papilloma, radial scar).
• \. 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.
• \. 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

Sponsors & Collaborators

• American College of Radiology: lead
• GE Healthcare: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (11)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute

Boca Raton, Florida, 33486, United States

RECRUITING

Lake Medical Imaging

The Villages, Florida, 32159, United States

ACTIVE NOT RECRUITING

Boston Breast Diagnostic Center

Wellesley Hills, Massachusetts, 02481, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Carolina Breast Imaging Specialists

Greenville, North Carolina, 27834, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22911, United States

RECRUITING

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Christopher Comstock, MD

CONTACT

212-746-6000; chc4050@med.cornell.edu

Etta Pisano, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Two independent readers at each institution participating in the trial will be assigned the task of either interpreting the results of the DBT images or the CESM images: one reader will read only the DBT images, while the other will read only the CESM images. Both individuals will be blinded to the results of the other modality, and the readers may not discuss their findings before both finalize their interpretations and complete the requisite CRFs.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants who meet eligibility criteria will be offered Contrast Enhanced Spectral Mammography (CESM) in addition to their routine annual screening Digital Breast Tomosynthesis (DBT) at both the year 0 and year 1 visits.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: March 24, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (10); CA (1)