Breast CarcinomaNCT05036083
Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion
A study testing Contrast-Enhanced Mammography, Digital Tomosynthesis Mammography and Electronic Health Record Review in people with Breast Carcinoma and Invasive Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Invasive Breast Carcinoma
- What is being tested?
- Contrast-Enhanced Mammography, Digital Tomosynthesis Mammography and Electronic Health Record Review
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging
- Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC)
- Willingness to participate in the study and ability to provide informed consent
Who cannot join
- Breast surgery within 6 months
- Known allergy to iodine-containing contrast agents
- History of anaphylactic reaction to any substance that required hospitalization or IV placement
- Renal insufficiency; hyperthyroidism
- Detection of non-breast primary or metastatic cancer in the breast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center
This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.
SECONDARY OBJECTIVES:
- To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.
II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.
III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis.
EXPLORATORY OBJECTIVES:
- To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort.
II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US.
III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions.
OUTLINE:
Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
After completion of study treatment, patients are followed up for 12 months.
- Conditions
- Breast Carcinoma, Invasive Breast Carcinoma
- Being tested
- Contrast-Enhanced Mammography, Digital Tomosynthesis Mammography, Electronic Health Record Review, Iodinated Contrast Agent
- 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 MammographyProcedure or surgery
Also called CEM
Undergo CEM
Digital Tomosynthesis MammographyProcedure or surgery
Also called DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast
Undergo DBT
Electronic Health Record ReviewOther
Medical records reviewed
Iodinated Contrast AgentDrug
Also called Iodinated Contrast Dye, Iodine-containing Contrast Media
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CEM, DBT, medical record) | Experimental | Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed. Receives: Procedure: Contrast-Enhanced Mammography; Procedure: Digital Tomosynthesis Mammography; Other: Electronic Health Record Review; Drug: Iodinated Contrast Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.
Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation)
*Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested
Measured: One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection
Secondary outcomes (4)
Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth.
Fraction of malignant lesions detected by each component of CEM
Measured: At presentation, Day 1
Percentage of Lesions That Appeared Larger on CEM
Largest measurements in imaging were compared to the largest measurements in pathology and the size difference of 5mm or more was considered significant. Fraction of patients in whom CEM detected an increase in lesion size of 5 mm or more was reported and analyzed.
Measured: One timepoint- at presentation
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation
Measured: 1 timepoint at presentation
Rate of Malignancy
Rate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy
Measured: One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start19 Mar 2021
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 89 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
- NCT05036083
- Sponsor's protocol ID
- 2020-1267
- Other IDs
- NCI-2021-08979, 2020-1267
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2021
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center
- ClinicalTrials.gov ID
- NCT05036083
- Acronym / sponsor ID
- 2020-1267
- Conditions
- Breast Carcinoma, Invasive Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 17 Sep 2025
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 investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.
Detailed description
PRIMARY OBJECTIVE:
- To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.
SECONDARY OBJECTIVES:
- To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.
II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.
III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis.
EXPLORATORY OBJECTIVES:
- To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort.
II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US.
III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions.
OUTLINE:
Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
After completion of study treatment, patients are followed up for 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CEM, DBT, medical record) | Experimental | Procedure: Contrast-Enhanced Mammography, Procedure: Digital Tomosynthesis Mammography, Other: Electronic Health Record Review, Drug: Iodinated Contrast AgentPatient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging
- Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC)
- Willingness to participate in the study and ability to provide informed consent
Key exclusion criteria (5 listed)
- Breast surgery within 6 months
- Known allergy to iodine-containing contrast agents
- History of anaphylactic reaction to any substance that required hospitalization or IV placement
- Renal insufficiency; hyperthyroidism
- Detection of non-breast primary or metastatic cancer in the breast
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 MammographyAlso: CEMUndergo CEM | Procedure or surgery | Diagnostic (CEM, DBT, medical record) |
| Digital Tomosynthesis MammographyAlso: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the BreastUndergo DBT | Procedure or surgery | Diagnostic (CEM, DBT, medical record) |
| Electronic Health Record ReviewMedical records reviewed | Other | Diagnostic (CEM, DBT, medical record) |
| Iodinated Contrast AgentAlso: Iodinated Contrast Dye, Iodine-containing Contrast MediaGiven IV | Drug | Diagnostic (CEM, DBT, medical record) |
Primary outcome
Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.
Time frame: One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection
Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation) *Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested
4 secondary outcomes
Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth.
Time frame: At presentation, Day 1
Percentage of Lesions That Appeared Larger on CEM
Time frame: One timepoint- at presentation
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Time frame: 1 timepoint at presentation
Rate of Malignancy
Time frame: One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Contrast-Enhanced Mammography, Digital Tomosynthesis Mammography and Electronic Health Record Review in people with Breast Carcinoma and Invasive 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 5 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: finished, as of the sponsor's last update on 17 Sep 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 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?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts. (time frame: One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection). 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 17 Sep 2025.