Breast CancerCMISTNCT05625659
Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts
A study testing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) in people with Breast Cancer, run by American College of Radiology at 13 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,032 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 24 Mar 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 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.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Etta Pisano, MD contact
13 sites in 2 countries
United States12 sites, 11 recruiting
- Recruiting
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Kathryn Zamora, MD, qmooney@uabmc.edu
- Recruiting
Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute
Boca Raton, Florida, 33486
Kathy Schilling, MD, gabrielle.mcnall@BaptistHealth.net
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Celine Ibrahim, cibrahim4@mgb.org
Michael Fishman, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22911
Ramapriya Ganti, MD, PhD, KLR3B@uvahealth.org
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Sabala Mandava, MD, CCTROBreastTeam@hfhs.org
- Recruiting
Carolina Breast Imaging Specialists
Greenville, North Carolina, 27834
Bruce Schroeder,, MD, schroeder@cbispecialists.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Olena Weaver, MD, BBBriones@mdanderson.org
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Tali Amir, MD, ziedenj@mskcc.org
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jason Shames, MD, Trang.Vu2@jefferson.edu
- Recruiting
Thomas Jefferson University
Sewell, New Jersey, 08080
Karishma Kurowski, MD, Karishma.Kurowski@jefferson.edu
Jason Shames, MD
- Active, not recruiting
Lake Medical Imaging
The Villages, Florida, 32159
- Recruiting
Boston Breast Diagnostic Center
Wellesley Hills, Massachusetts, 02481
Jordana Phillips, MD
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Hospital
London, Ontario, N6A 4V2
Anat Kornecki, MD, deepanjali.kaushik@sjhc.london.on.ca
About this study
Official title: 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
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.
Read the detailed description
The Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST), which will be managed by the American College of Radiology (ACR), Center for Research and Innovation (CRI), seeks to determine if dual-energy contrast-enhanced spectral mammography (CESM) screening provides more accurate cancer detection compared to digital breast tomosynthesis (DBT) in women with dense breasts.
Year 0 Visit:
All women aged 45 to 74 years of age known mammographically dense breasts, as reported on their most recent prior mammogram who are scheduled for a routine annual screening DBT will be offered CESM in addition to DBT. Baseline imaging (Year 0) will be performed within 30 days after participant registration. Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup.
Year 1 Visit (12 Months ±2 Months After Year 0 Imaging):
Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup.
Year 2 Visit: Follow-Up - Return for Standard Mammography Screening (12 Months ±2 Months After Year 1 Imaging):
The 2-year participant follow-up contact (email, text, or phone calls) should be performed 12 months (±2 months) after the Year 1 imaging to confirm the participant has not been diagnosed with an interval breast cancer. If 2-year imaging has not been scheduled, the 2-year participant follow-up contact should be performed prior to 14 months post year 1 visit. Participants diagnosed with breast cancer in the interval between the Year 1 and Year 2 imaging studies will have no subsequent follow-up and will not undergo the Year 2 study imaging in the scope of the study. The participant will be asked for AEs/SAEs with a non-leading question.
- Conditions
- Breast Cancer
- Being tested
- Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| DBT and CESM Diagnostic Imaging in Women with Dense Breasts | Other | Interventional Diagnostic Receives: Diagnostic Test: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Detection Rate
The cancer detection rate (CDR) at the participant level at Year 0. This measure will be evaluated for CESM and DBT
Measured: Year 0
Recall Rate
The recall rate for participants at Year 1, which will be estimated for each imaging modality separately.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start24 Mar 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants who meet eligibility criteria will be offered Contrast Enhanced Spectral Mammography (CESM) in addition to their routine annual screening Digital Breast Tomosynthesis (DBT) at both the year 0 and year 1 visits.
- Masking
- None (open label)
- Enrolment
- 2,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, Breast Cancer Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625659
- Sponsor's protocol ID
- ACR A4707
- Acronym
- CMIST
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05625659
- Acronym / sponsor ID
- CMIST / ACR A4707
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,032 participants (estimated)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Collaborators
- GE Healthcare, Breast Cancer Research Foundation
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST), which will be managed by the American College of Radiology (ACR), Center for Research and Innovation (CRI), seeks to determine if dual-energy contrast-enhanced spectral mammography (CESM) screening provides more accurate cancer detection compared to digital breast tomosynthesis (DBT) in women with dense breasts.
Year 0 Visit:
All women aged 45 to 74 years of age known mammographically dense breasts, as reported on their most recent prior mammogram who are scheduled for a routine annual screening DBT will be offered CESM in addition to DBT. Baseline imaging (Year 0) will be performed within 30 days after participant registration. Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup.
Year 1 Visit (12 Months ±2 Months After Year 0 Imaging):
Standard DBT screening views followed by standard CESM screening views will be performed on the same day and prior to any additional workup.
Year 2 Visit: Follow-Up - Return for Standard Mammography Screening (12 Months ±2 Months After Year 1 Imaging):
The 2-year participant follow-up contact (email, text, or phone calls) should be performed 12 months (±2 months) after the Year 1 imaging to confirm the participant has not been diagnosed with an interval breast cancer. If 2-year imaging has not been scheduled, the 2-year participant follow-up contact should be performed prior to 14 months post year 1 visit. Participants diagnosed with breast cancer in the interval between the Year 1 and Year 2 imaging studies will have no subsequent follow-up and will not undergo the Year 2 study imaging in the scope of the study. The participant will be asked for AEs/SAEs with a non-leading question.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants who meet eligibility criteria will be offered Contrast Enhanced Spectral Mammography (CESM) in addition to their routine annual screening Digital Breast Tomosynthesis (DBT) at both the year 0 and year 1 visits.
| Arm | Type | Receives |
|---|---|---|
| DBT and CESM Diagnostic Imaging in Women with Dense Breasts | Other | Diagnostic Test: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM)Interventional Diagnostic |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (18 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | DBT and CESM Diagnostic Imaging in Women with Dense Breasts |
Primary outcome
Cancer Detection Rate
Time frame: Year 0
The cancer detection rate (CDR) at the participant level at Year 0. This measure will be evaluated for CESM and DBT
Recall Rate
Time frame: 1 Year
The recall rate for participants at Year 1, which will be estimated for each imaging modality separately.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Etta Pisano, MD contact
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) in people with Breast Cancer, run by American College of Radiology at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Comstock, MD (212-746-6000, chc4050@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Detection Rate (time frame: Year 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.