Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-74
SponsorAmerican College of Radiology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)
Diagnostic testIn 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.
Treatment groups
2,032 Participants
are divided into 1 treatment groupGroup A: DBT and CESM Diagnostic Imaging in Women with Dense BreastsOther 1 intervention
Trial outcomes
Primary outcomes
1
Cancer Detection Rate
The cancer detection rate (CDR) at the participant level at Year 0. This measure will be evaluated for CESM and DBT
Time frame
Year 02
Recall Rate
The recall rate for participants at Year 1, which will be estimated for each imaging modality separately.
Time frame
1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
American College of Radiology
Lead sponsor
GE Healthcare
Collaborator
Breast Cancer Research Foundation
Collaborator
Source ClinicalTrials.gov