RecruitingNot applicable

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

Comparison of Breast Cancer Screening With Dual-Energy Contrast-Enhanced Spectral Mammography to Digital Breast Tomosynthesis in Women With Dense Breasts (Contrast Mammography Imaging Screening Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 74 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two breast cancer screening tests in women with dense breasts: CESM, a mammogram that uses dye given through a vein, and DBT, a 3D mammogram. It tests whether CESM finds more cancers with fewer false alarms at the first screening and again 1 year later.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your latest screening mammogram showed dense or very dense breast tissue.
  • You agree not to have whole-breast screening ultrasound until your usual imaging in year 2.
  • You have no signs of breast disease, such as a lump, pain in one spot, or bloody or clear fluid from a nipple.
  • You can safely receive iodine-based dye through a vein, with no known allergy-like reaction to iodine or moderate or severe allergic reactions to other substances.
  • You are not pregnant or breastfeeding. A negative pregnancy test may be needed before you receive the dye.
  • If you could become pregnant, you will be strongly advised to use effective birth control or avoid sex until the year 1 study tests.

Who can't join

  • You are being treated for breast cancer or plan surgery for a breast growth or tissue change linked to higher cancer risk.
  • You had a mammogram or screening breast ultrasound within the past 11 months.
  • You had breast MRI, CESM, or molecular breast imaging (MBI) within the past 36 months.
  • You have silicone or saline breast implants, or your breasts need several images for each standard view.
  • Your estimated lifetime breast cancer risk is 20%–25% or higher, unless you cannot have an MRI.
  • You have a history of sickle cell disease, an inherited blood disorder.
  • You have known or suspected kidney problems. The study site decides whether kidney function testing is needed.
  • You are pregnant, breastfeeding, or planning pregnancy between screening and 30 days after your last dose of study dye.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (12)

AL

FL

MA

MI

NC

NJ

NY

PA

TX

VA