Testing Dual-Energy Contrast-Enhanced Spectral for breast cancer
Official title: 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
Interventions
Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)
In 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.
Canadian Sites (1)
St. Joseph's Hospital
London, Ontario, Canada
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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).
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +2\. Women agree to not undergo whole breast screening ultrasound for the duration of the trial until the year 2 standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → 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).
- +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 siteTrial siteA hospital or clinic where a study is actually run.Read more → 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
- −2\. Women who have had the following are not eligible:
- −a mammogram less than 11 months prior to study entry.
- −screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 siteTrial siteA hospital or clinic where a study is actually run.Read more → standard practice. Criteria that should be considered include, but are not limited to, the following:
- −Age \>60 years old
- −History of hypertension requiring medical therapy
- −History of diabetes mellitus
- −Use of metformin or metformin-containing drug combinations
- −5\. Large breasted women that require multiple images per standard view of the breast (Tiling) as determined by their most recent mammogram.
- −4\. Women who are pregnant, breast feeding, or planning to become pregnant from screening until 30 days after the last administration of Omnipaque (iohexol).
- −1\. Women currently undergoing treatment for breast cancer, or planning surgery for a high-risk lesion (ADH, ALH, LCIS, papilloma, radial scar).
- −History of renal disease, including dialysis, kidney transplant, single kidney, renal cancer, and renal surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 45 years to 74 years.
The study lists female participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,032 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: Year 0.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Cancer Detection Rate — measured over Year 0.
Recall Rate — measured over 1 Year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05625659 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)Diagnostic test
In 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.
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 45 years to 74 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 45 years to 74 years.
It lists female participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Year 0.
The study as a whole is currently expected to finish around 2027-07-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,032 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: London, Ontario, Canada; Detroit, Michigan, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (2)
Henry Ford Health
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.