Clinical trial for Breast Cancer
Official title Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
ClinicalTrials.gov ID: NCT05625659
What this study is testing
- What it's testing
- The study wants to see if CESM finds more cancers and gives fewer false alarms than DBT. It will compare the two tests at the first screening and again one year later.
- Who it's for
- Women who have dense breast tissue and are eligible for routine breast‑cancer screening.
- What's involved
- Participants will have two different breast‑screening exams, one with CESM and one with DBT, at the start of the study and again after one year. They may also have follow‑up tests if something looks abnormal.
- Time commitment
- The study lasts about one year, with two screening visits (baseline and 12‑month follow‑up) and any additional tests that are needed after each screening.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 74, women only. Healthy volunteers may be eligible.
You may be able to join if
- 1\. Women must have mammographically dense breasts, ACR BI-RADS® lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their...
- 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...
- 4\. Women must be able to undergo intravenous (IV) administration of iodinated contrast (e.g., no contraindication to intravenous contrast...
- 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...
You likely can't join if
- 1\. Women currently undergoing treatment for breast cancer, or planning surgery for a high-risk lesion (ADH, ALH, LCIS, papilloma, radial scar).
- 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.
See the full eligibility 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...
- 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...
- 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...
- 1\. Women currently undergoing treatment for breast cancer, or planning surgery for a high-risk lesion (ADH, ALH, LCIS, papilloma, radial scar).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Boca Raton, Florida, United States
- Boston, Massachusetts, United States
- Wellesley Hills, Massachusetts, United States
- Detroit, Michigan, United States
- Sewell, New Jersey, United States
- New York, New York, United States
- Greenville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Boca Raton, Florida, United States; Boston, Massachusetts, United States; Wellesley Hills, Massachusetts, United States; Detroit, Michigan, United States; Sewell, New Jersey, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.