Breast CarcinomaNCT05046301
Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications
An observational study of Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Read more about this study
- Who is it for?
- Ages 25 to 85 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Contrast Agent and Contrast-Enhanced Mammography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2021to 2 Feb 2027
- Phase
- Observational
- 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 25 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspicious mammographic microcalcifications
Who may be able to join
- Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System [BI-RADS] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and recommended for a stereotactic biopsy, who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their stereotactic biopsy at MDACC.
- Age 25-85 years
- Willing to participate in the study, undergo an intravenous (IV) placement, able to undergo iodinated contrast injection, and able to provide informed consent
Who cannot join
- Reported history of an allergic reaction to iodinated contrast
- History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
- Renal insufficiency
- Pregnancy or lactation within 6 months
- Breast surgery affecting the site of interest within prior 6 months
- Breast biopsy at the site of interest within the last 2 months
- Mammographic mass or architectural distortion associated with the calcifications in question
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast-Enhanced Mammography (CEM) and CEM-Directed Biopsy for the Evaluation of Extensive Suspicious Mammographic Microcalcifications
This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the added value of contrast enhancement of CEM compared to two dimensional (2D) mammography in predicting invasive malignancy or high-grade DCIS in patients with suspicious mammographic microcalcifications.
SECONDARY OBJECTIVES:
- To evaluate the added value of contrast enhancement in CEM by comparing the sensitivity/specificity of contrast enhancement to the sensitivity/specificity of FFDM.
II. To evaluate whether the absence of contrast enhancement can predict the absence of high grade DCIS or invasive cancer by establishing the negative predictive value (NPV) of contrast enhancement and comparing it to the NPV of FFDM.
III To evaluate whether the presence of abnormal contrast enhancement can predict the presence of high grade DCIS or invasive malignancy by establishing the positive predictive value (PPV) of contrast enhancement and comparing it to the PPV of FFDM.
IV. To evaluate the influence of the morphology, distribution, and extent of mammographic microcalcifications on the presence and intensity of contrast enhancement.
- To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM findings.
EXPLORATORY OBJECTIVES:
- To evaluate the correlation of blood biomarkers and the presence of invasive cancer and high-grade DCIS on pathology in the study patients.
II. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious microcalcifications equal to or exceeding 4 cm in diameter.
III. In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high grade lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
IV. To compare the performance of FFDM (obtained as a part of the recent prior screening or diagnostic mammographic work-up) and LE CEM images (obtained as a part of the CEM study) in terms of accuracy, sensitivity, specificity, PPV and NPV.
OUTLINE:
Patients complete a questionnaire and undergo collection of a blood sample. Patients receive contrast intravenously (IV) and undergo CEM.
After completion of study, patients are followed for 24 months.
- Conditions
- Breast Carcinoma
- Being tested
- Biospecimen Collection, Contrast Agent, Contrast-Enhanced Mammography, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Correlative studies
Contrast AgentOther
Also called Contrast, Contrast Drugs, contrast material, Contrast Medium
Given IV
Contrast-Enhanced MammographyProcedure or surgery
Also called CEM
Undergo contrast-enhanced mammography
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (contrast-enhanced mammography) | Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM. Receives: Procedure: Biospecimen Collection; Other: Contrast Agent; Procedure: Contrast-Enhanced Mammography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Determined by comparing the contrast-enhanced mammography (CEM)/full field digital mammography (FFDM) results to those of the pathologic evaluations. Specifically, it is defined as the number of concordant cases between CEM/FFDM and pathologic evaluation divided by the total sample size. Descriptive statistics will be used to summarize clinical variables of interest. Specifically, categorical measures will be summarized using frequencies and percentages, and continuous measures will be summarized using means, standard deviations, medians, and ranges.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start23 Mar 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olena Weaver, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046301
- Sponsor's protocol ID
- 2020-0501
- Other IDs
- NCI-2021-08428
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Mammography (CEM) and CEM-Directed Biopsy for the Evaluation of Extensive Suspicious Mammographic Microcalcifications
- ClinicalTrials.gov ID
- NCT05046301
- Acronym / sponsor ID
- 2020-0501
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 16 Sep 2021 (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 clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the added value of contrast enhancement of CEM compared to two dimensional (2D) mammography in predicting invasive malignancy or high-grade DCIS in patients with suspicious mammographic microcalcifications.
SECONDARY OBJECTIVES:
- To evaluate the added value of contrast enhancement in CEM by comparing the sensitivity/specificity of contrast enhancement to the sensitivity/specificity of FFDM.
II. To evaluate whether the absence of contrast enhancement can predict the absence of high grade DCIS or invasive cancer by establishing the negative predictive value (NPV) of contrast enhancement and comparing it to the NPV of FFDM.
III To evaluate whether the presence of abnormal contrast enhancement can predict the presence of high grade DCIS or invasive malignancy by establishing the positive predictive value (PPV) of contrast enhancement and comparing it to the PPV of FFDM.
IV. To evaluate the influence of the morphology, distribution, and extent of mammographic microcalcifications on the presence and intensity of contrast enhancement.
- To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM findings.
EXPLORATORY OBJECTIVES:
- To evaluate the correlation of blood biomarkers and the presence of invasive cancer and high-grade DCIS on pathology in the study patients.
II. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious microcalcifications equal to or exceeding 4 cm in diameter.
III. In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high grade lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
IV. To compare the performance of FFDM (obtained as a part of the recent prior screening or diagnostic mammographic work-up) and LE CEM images (obtained as a part of the CEM study) in terms of accuracy, sensitivity, specificity, PPV and NPV.
OUTLINE:
Patients complete a questionnaire and undergo collection of a blood sample. Patients receive contrast intravenously (IV) and undergo CEM.
After completion of study, patients are followed for 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (contrast-enhanced mammography) | – | Procedure: Biospecimen Collection, Other: Contrast Agent, Procedure: Contrast-Enhanced Mammography, Other: Questionnaire AdministrationPatients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicious mammographic microcalcifications
Key inclusion criteria (3 listed)
- Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System [BI-RADS] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and recommended for a stereotactic biopsy, who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their stereotactic biopsy at MDACC.
- Age 25-85 years
- Willing to participate in the study, undergo an intravenous (IV) placement, able to undergo iodinated contrast injection, and able to provide informed consent
Key exclusion criteria (7 listed)
- Reported history of an allergic reaction to iodinated contrast
- History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
- Renal insufficiency
- Pregnancy or lactation within 6 months
- Breast surgery affecting the site of interest within prior 6 months
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample CollectionCorrelative studies | Procedure or surgery | Diagnostic (contrast-enhanced mammography) |
| Contrast AgentAlso: Contrast, Contrast Drugs, contrast material, Contrast MediumGiven IV | Other | Diagnostic (contrast-enhanced mammography) |
| Contrast-Enhanced MammographyAlso: CEMUndergo contrast-enhanced mammography | Procedure or surgery | Diagnostic (contrast-enhanced mammography) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (contrast-enhanced mammography) |
Primary outcome
Accuracy
Time frame: Up to 1 year
Determined by comparing the contrast-enhanced mammography (CEM)/full field digital mammography (FFDM) results to those of the pathologic evaluations. Specifically, it is defined as the number of concordant cases between CEM/FFDM and pathologic evaluation divided by the total sample size. Descriptive statistics will be used to summarize clinical variables of interest. Specifically, categorical measures will be summarized using frequencies and percentages, and continuous measures will be summarized using means, standard deviations, medians, and ranges.
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 12 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Olena Weaver principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Up to 1 year). 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 12 Aug 2026.