Breast CancerCEMNCT06993246
Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?
A study testing Contrast-Enhanced Mammography (CEM) in people with Breast Cancer, run by Jean Seely at 1 site in Canada.
Trial summary
This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast-Enhanced Mammography (CEM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2025to 30 Sep 2028
- 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 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
- Women ages 50-69 years of age
- Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
- Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
- No evidence of renal disease
Who cannot join
- Patients with renal insufficiency (reduced eGFR <20ml/min)
- Previous allergic reactions to Iodine-based contrast.
- Prior contrast allergy (CT contrast)
- Thyroid Disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC contact
Dr. Betty Anne Schwarz, Director of Research Services, DProf, RN BA MSc contact
Canada1 site
The Ottawa Hospital
Ottawa, Ontario, K1H 9L6
Dr. Jean Seely Principal Investigator, MD FRCPC, jeseely@toh.on.ca
About this study
Official title: Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.
This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.
Read the detailed description
Primary Outcome Measure: 1. Detection Rate of Breast Cancer The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.
- Conditions
- Breast Cancer
- Being tested
- Contrast-Enhanced Mammography (CEM)
- Keywords
- Mammography screening, Contrast-Enhanced Mammography, Dense breasts
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced Mammography (CEM)Diagnostic test
The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effective alternative to MRI, with comparable sensitivity in detecting breast cancer. Participants will undergo the CEM procedure in a single visit, allowing for reduced wait times and improved detection rates compared to traditional methods. The procedure is well-tolerated, with minimal side effects, and provides a quicker and more accessible option for supplemental breast cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| **Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening** | Experimental | This arm involves participants undergoing Contrast-Enhanced Mammography (CEM) as a supplemental screening method for breast cancer. CEM combines standard mammography with iodinated contrast medium to improve lesion visualization and tumor detection, particularly in women with dense breast tissue. Participants will receive CEM during a single visit at the Rose Ages Breast Health Centre, and their results will be evaluated for cancer detection, abnormal interpretation rates, and biopsy outcomes. Receives: Diagnostic Test: Contrast-Enhanced Mammography (CEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rate of Breast Cancer
The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.
Measured: Three years from the study start date.
Secondary outcomes (2)
Lesion Characterization
Assessment of the ability of CEM to accurately characterize breast lesions in terms of malignancy (benign or malignant). This will be evaluated by comparing CEM findings with biopsy results.
Measured: Up to one year.
Patient Experience
A patient-reported survey measuring comfort, satisfaction, and perceived usefulness of CEM compared to traditional mammography.
Measured: Immediate post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2028 (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
- The study follows a \*\*prospective cohort design\*\*, where eligible participants are recruited and followed over time to evaluate the outcomes of Contrast-Enhanced Mammography (CEM) in comparison to traditional screening methods like ultrasound and MRI. Participants are women aged 50-69 years with dense breast tissue and a personal history of breast cancer. They will undergo CEM as part of their routine screening process. The study aims to assess key outcomes, including cancer detection rates, biopsy results, patient acceptance, and screening wait times. Data will be collected on screening outcomes, including abnormal interpretation rates, positive predictive values, and follow-up results over two years. The study also compares the performance of CEM with historical data from previous screening modalities.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean Seely
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor-investigator, Jean Seely, Ottawa Hospital Research Institute
- Investigators
- Dr. Jean Seely Principal Investigator,, MD FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993246
- Sponsor's protocol ID
- OHSN- REB 20240828-01H
- Acronym
- CEM
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06993246
- Acronym / sponsor ID
- CEM / OHSN- REB 20240828-01H
- Conditions
- Breast Cancer
- Keywords
- Mammography screening, Contrast-Enhanced Mammography, Dense breasts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jean SeelyUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 28 May 2025 (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.
This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.
Detailed description
Primary Outcome Measure: 1. Detection Rate of Breast Cancer The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study follows a prospective cohort design, where eligible participants are recruited and followed over time to evaluate the outcomes of Contrast-Enhanced Mammography (CEM) in comparison to traditional screening methods like ultrasound and MRI. Participants are women aged 50-69 years with dense breast tissue and a personal history of breast cancer. They will undergo CEM as part of their routine screening process. The study aims to assess key outcomes, including cancer detection rates, biopsy results, patient acceptance, and screening wait times. Data will be collected on screening outcomes, including abnormal interpretation rates, positive predictive values, and follow-up results over two years. The study also compares the performance of CEM with historical data from previous screening modalities.
| Arm | Type | Receives |
|---|---|---|
| **Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening** | Experimental | Diagnostic Test: Contrast-Enhanced Mammography (CEM)This arm involves participants undergoing Contrast-Enhanced Mammography (CEM) as a supplemental screening method for breast cancer. CEM combines standard mammography with iodinated contrast medium to improve lesion visualization and tumor detection, particularly in women with dense breast tissue. Participants will receive CEM during a single visit at the Rose Ages Breast Health Centre, and their results will be evaluated for cancer detection, abnormal interpretation rates, and biopsy outcomes. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
- Women ages 50-69 years of age
- Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
- Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
- No evidence of renal disease
Key exclusion criteria (4 listed)
- Patients with renal insufficiency (reduced eGFR <20ml/min)
- Previous allergic reactions to Iodine-based contrast.
- Prior contrast allergy (CT contrast)
- Thyroid Disease
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 |
|---|---|---|
| Contrast-Enhanced Mammography (CEM)The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effective alternative to MRI, with comparable sensitivity in detecting breast cancer. Participants will undergo the CEM procedure in a single visit, allowing for reduced wait times and improved detection rates compared to traditional methods. The procedure is well-tolerated, with minimal side effects, and provides a quicker and more accessible option for supplemental breast cancer screening. | Diagnostic test | **Contrast-Enhanced Mammography for Supplemental Breast Cancer Screening** |
Primary outcome
Detection Rate of Breast Cancer
Time frame: Three years from the study start date.
The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.
2 secondary outcomes
Lesion Characterization
Time frame: Up to one year.
Patient Experience
Time frame: Immediate post-procedure.
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 28 May 2025.
- Individual participant dataSharing planned: No. Only aggregate data will be shared.
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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.
Dr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC contact
Dr. Betty Anne Schwarz, Director of Research Services, DProf, RN BA MSc contact
Dr. Jean Seely Principal Investigator,, MD FRCPC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-Enhanced Mammography (CEM) in people with Breast Cancer, run by Jean Seely at 1 site in Canada.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Dr. Jean Seely Department of Radiology, Radiation Oncology, MD, FRCPC, MD, FRCPC (613-737-8899 ext. Ext. 73665, jeseely@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection Rate of Breast Cancer (time frame: Three years from the study start date.). 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 28 May 2025.