Breast CarcinomaNCT04871139
An Imaging Technology, Contrast-Enhanced Mammography, in Predicting Breast Cancer
A study testing Biopsy, Contrast-Enhanced Mammography and Questionnaire Administration in people with Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Biopsy, Contrast-Enhanced Mammography and Questionnaire Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 1 Mar 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with suspicious MADs 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 biopsy at MDACC
- Age 25-85 years
- Willing to participate in the study, undergo an 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the added value of contrast enhancement of contrast-enhanced mammography (CEM) compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with suspicious mammographic architectural distortion (MAD)s.
SECONDARY OBJECTIVES:
- To compare sensitivity, specificity, negative predictive value and positive predictive value of CEM versus FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS in patients with suspicious MADs.
II. To evaluate whether the presence of enhancement on CEM correlates with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy.
III. To estimate the proportion of cases in which CEM changes the original target for a stereotactic biopsy.
IV. 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 DCIS on pathology in the study patients.
II. To evaluate the role of CEM enhancement pattern in choosing a precise target for a stereotactic biopsy.
III. To develop an objective method of quantifying the degree of enhancement above background using AI-based digital image analysis.
IV. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious MADs.
- In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to DCIS or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
VI. 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, positive predictive value (PPV) and negative predictive value (NPV) for the detection of invasive cancer and high-grade DCIS.
OUTLINE:
Patients receive iodine-based contrast agent intravenously (IV) and the undergo CEM over 10-15 minutes.
- Conditions
- Breast Carcinoma
- Being tested
- Biopsy, Contrast-Enhanced Mammography, Questionnaire Administration, Radioactive Iodine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Contrast-Enhanced MammographyProcedure or surgery
Also called CEM
Undergo CEM
Questionnaire AdministrationOther
Ancillary studies
Radioactive IodineOther
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (iodine-based contrast, CEM) | Experimental | Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes. Receives: Procedure: Biopsy; Procedure: Contrast-Enhanced Mammography; Other: Questionnaire Administration; Other: Radioactive Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of contrast-enhanced mammography (CEM)
Will examine the accuracy of CEM compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with mammographic architectural distortion (MAD)s.
Measured: Up to 3 years
Secondary outcomes (7)
Sensitivity of CEM, FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS
Will compare the sensitivity of CEM with that of FFDM, DBT, and US in predicting invasive malignancy or DCIS by using McNemar's test.
Measured: Up to 3 years
Specificity of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
Will compare the specificity of CEM with that of FFDM, DBT, and US in predicting invasive malignancy or DCIS by using McNemar's test
Measured: Up to 3 years
Negative predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
Measured: Up to 3 years
Positive predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
Measured: Up to 3 years
Degree of enhancement on CEM
Will examine the degree of enhancement on CEM and its correlation with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy.
Measured: Up to 3 years
Proportion of cases in which CEM changes the original target for a stereotactic biopsy
We will estimate the proportion of cases in which CEM changes the original target along with an exact 95% confidence interval.
Measured: Up to 3 years
Cancer detection rate
Will examine cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM findings.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start8 Apr 2021
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Olena Weaver, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871139
- Sponsor's protocol ID
- 2021-0031
- Other IDs
- NCI-2021-03404, 2021-0031
- Status last verified
- Sep 2026
- First submitted
- 1 May 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
- ClinicalTrials.gov ID
- NCT04871139
- Acronym / sponsor ID
- 2021-0031
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 May 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 examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the added value of contrast enhancement of contrast-enhanced mammography (CEM) compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with suspicious mammographic architectural distortion (MAD)s.
SECONDARY OBJECTIVES:
- To compare sensitivity, specificity, negative predictive value and positive predictive value of CEM versus FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS in patients with suspicious MADs.
II. To evaluate whether the presence of enhancement on CEM correlates with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy.
III. To estimate the proportion of cases in which CEM changes the original target for a stereotactic biopsy.
IV. 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 DCIS on pathology in the study patients.
II. To evaluate the role of CEM enhancement pattern in choosing a precise target for a stereotactic biopsy.
III. To develop an objective method of quantifying the degree of enhancement above background using AI-based digital image analysis.
IV. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious MADs.
- In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to DCIS or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
VI. 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, positive predictive value (PPV) and negative predictive value (NPV) for the detection of invasive cancer and high-grade DCIS.
OUTLINE:
Patients receive iodine-based contrast agent intravenously (IV) and the undergo CEM over 10-15 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (iodine-based contrast, CEM) | Experimental | Procedure: Biopsy, Procedure: Contrast-Enhanced Mammography, Other: Questionnaire Administration, Other: Radioactive IodinePatients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with suspicious MADs 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 biopsy at MDACC
- Age 25-85 years
- Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent
Key exclusion criteria (6 listed)
- Reported history of an allergic reaction to iodinated contrast
- History of anaphylactic reaction to any substance
- 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 |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Diagnostic (iodine-based contrast, CEM) |
| Contrast-Enhanced MammographyAlso: CEMUndergo CEM | Procedure or surgery | Diagnostic (iodine-based contrast, CEM) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (iodine-based contrast, CEM) |
| Radioactive IodineGiven IV | Other | Diagnostic (iodine-based contrast, CEM) |
Primary outcome
Accuracy of contrast-enhanced mammography (CEM)
Time frame: Up to 3 years
Will examine the accuracy of CEM compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with mammographic architectural distortion (MAD)s.
7 secondary outcomes
Sensitivity of CEM, FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS
Time frame: Up to 3 years
Specificity of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
Time frame: Up to 3 years
Negative predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
Time frame: Up to 3 years
Positive predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS
Time frame: Up to 3 years
Degree of enhancement on CEM
Time frame: Up to 3 years
Proportion of cases in which CEM changes the original target for a stereotactic biopsy
Time frame: Up to 3 years
Cancer detection rate
Time frame: Up to 3 years
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 18 Sep 2026.
- M D 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?
A study testing Biopsy, Contrast-Enhanced Mammography and Questionnaire Administration in people with 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 6 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 18 Sep 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 of contrast-enhanced mammography (CEM) (time frame: Up to 3 years). 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 18 Sep 2026.