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New treatment option 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 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.
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).
- 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.
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).
- 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.
- 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...
- 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's taking place
- Birmingham, Alabama, United States
- Boca Raton, Florida, United States
- The Villages, Florida, 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 - 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?
Study sites include Birmingham, Alabama, United States; Boca Raton, Florida, United States; The Villages, Florida, United States; Wellesley Hills, Massachusetts, United States; Detroit, Michigan, United States; Sewell, New Jersey, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.