Comparing two breast cancer screening methods for women with dense breasts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of dual-energy contrast-enhanced spectral mammography (CESM) compared to digital breast tomosynthesis (DBT) in detecting breast cancer in women with dense breast tissue. Participants aged 45 to 74 with mammographically dense breasts will undergo both CESM and DBT screenings at baseline and again after one year. The study will assess the accuracy of cancer detection and the rate of false positives between the two imaging techniques. Follow-up will occur to ensure participants have not been diagnosed with interval breast cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).
  7. 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)
  8. a history of sickle cell disease.
* 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.

Where it's running

• University of Alabama, Birmingham
  Birmingham, Alabama, United States Recruiting
• Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute
  Boca Raton, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Boston Breast Diagnostic Center
  Wellesley Hills, Massachusetts, United States Recruiting
• Henry Ford Health
  Detroit, Michigan, United States Recruiting
• Thomas Jefferson University
  Sewell, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Christopher Comstock, MD
• Email: chc4050@med.cornell.edu
• Phone: 212-746-6000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.