Breast CarcinomaNCT05056844
Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge
A study testing Contrast Enhanced Digital Mammography, Digital Tomosynthesis Mammography and Iodinated Contrast Agent in people with Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) 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 25 to 85 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Contrast Enhanced Digital Mammography, Digital Tomosynthesis Mammography and Iodinated Contrast Agent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 30 Apr 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 25 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom
- Age 25-85 years
- Willing to participate in the study and 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 in the absence of a prior history of uneventful administration of iodine-based IV contrast.
- Renal insufficiency
- Pregnancy or lactation within 6 months
- Breast surgery affecting the symptomatic breast within prior 6 months, if it was located within 5 cm from the nipple
- Breast biopsy of the symptomatic breast within the last 2 months, if it was located within 5 cm from the nipple
- Breast MRI performed within 24 months before the patient presented with qualifying symptoms (MRI performed contemporarily with CEM for the evaluation of new symptoms is not an exclusion criterion).
- Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study
This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the added sensitivity of contrast enhancement of CESM (represented by the subtracted contrast images of CESM) compared to low energy [LE] images of CESM (full field digital mammogram [FFDM] equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ [DCIS], atypia, or papilloma) in patients with pathologic nipple discharge (PND).
SECONDARY OBJECTIVES:
- To compare the sensitivity, specificity, negative predictive value, and positive predictive value of CESM versus DBT and ultrasound (US) in predicting invasive malignancy or DCIS in patients with PND.
II. To compare the accuracy of digital breast tomosynthesis (DBT) and LE in the detection of invasive malignancy or DCIS, as well as in the detection of the causative lesion.
III. To estimate the proportion of cases in which CESM affects the choice of the lesion targeted for a biopsy with any imaging modality.
IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CESM 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 the CESM enhancement pattern in choosing a precise target for a stereotactic biopsy.
III. To evaluate the effect of CESM on the patient workflow by calculating the time from presentation to the definitive diagnosis.
IV. To evaluate the technical feasibility of using CESM- guided or CESM directed biopsies.
- In patients who undergo a CESM targeted or CESM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
VI. In those study patients who undergo breast MRI as a part of their clinical care, the sensitivity and specificity of magnetic resonance imaging (MRI) and CESM for the detection of causative lesions will be compared.
OUTLINE:
Patients receive iodine-based contrast agent intravenously (IV) then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.
- Conditions
- Breast Carcinoma
- Being tested
- Contrast Enhanced Digital Mammography, Digital Tomosynthesis Mammography, Iodinated Contrast Agent, 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.
Contrast Enhanced Digital MammographyProcedure or surgery
Also called CEDM, Contrast Enhanced Spectral Mammography, Contrast-Enhanced Digital Mammography, Contrast Enhanced Mammography
Undergo CESM
Digital Tomosynthesis MammographyProcedure or surgery
Also called DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast
Undergo DBT
Iodinated Contrast AgentDrug
Also called Iodinated Contrast Dye, Iodine-containing Contrast Media
Given iodine-based contrast agent IV
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CESM, DBT) | Experimental | Patients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT. Receives: Procedure: Contrast Enhanced Digital Mammography; Procedure: Digital Tomosynthesis Mammography; Drug: Iodinated Contrast Agent; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)
Will be compared to low exposure (LE) images of CESM (full field digital mammogram equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ (DCIS), atypia, or papilloma) in patients with pathologic nipple discharge (PND).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start15 Apr 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olena Weaver, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056844
- Sponsor's protocol ID
- 2021-0025
- Other IDs
- NCI-2021-07594, 2021-0025
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2021
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study
- ClinicalTrials.gov ID
- NCT05056844
- Acronym / sponsor ID
- 2021-0025
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 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 studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the added sensitivity of contrast enhancement of CESM (represented by the subtracted contrast images of CESM) compared to low energy [LE] images of CESM (full field digital mammogram [FFDM] equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ [DCIS], atypia, or papilloma) in patients with pathologic nipple discharge (PND).
SECONDARY OBJECTIVES:
- To compare the sensitivity, specificity, negative predictive value, and positive predictive value of CESM versus DBT and ultrasound (US) in predicting invasive malignancy or DCIS in patients with PND.
II. To compare the accuracy of digital breast tomosynthesis (DBT) and LE in the detection of invasive malignancy or DCIS, as well as in the detection of the causative lesion.
III. To estimate the proportion of cases in which CESM affects the choice of the lesion targeted for a biopsy with any imaging modality.
IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CESM 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 the CESM enhancement pattern in choosing a precise target for a stereotactic biopsy.
III. To evaluate the effect of CESM on the patient workflow by calculating the time from presentation to the definitive diagnosis.
IV. To evaluate the technical feasibility of using CESM- guided or CESM directed biopsies.
- In patients who undergo a CESM targeted or CESM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to in-situ or invasive cancer for those patients who will require surgery as a part of their routine clinical care.
VI. In those study patients who undergo breast MRI as a part of their clinical care, the sensitivity and specificity of magnetic resonance imaging (MRI) and CESM for the detection of causative lesions will be compared.
OUTLINE:
Patients receive iodine-based contrast agent intravenously (IV) then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CESM, DBT) | Experimental | Procedure: Contrast Enhanced Digital Mammography, Procedure: Digital Tomosynthesis Mammography, Drug: Iodinated Contrast Agent, Other: Questionnaire AdministrationPatients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom
- Age 25-85 years
- Willing to participate in the study and undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent
Key exclusion criteria (8 listed)
- Reported history of an allergic reaction to iodinated contrast
- History of anaphylactic reaction to any substance in the absence of a prior history of uneventful administration of iodine-based IV contrast.
- Renal insufficiency
- Pregnancy or lactation within 6 months
- Breast surgery affecting the symptomatic breast within prior 6 months, if it was located within 5 cm from the nipple
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 Digital MammographyAlso: CEDM, Contrast Enhanced Spectral Mammography, Contrast-Enhanced Digital Mammography, Contrast Enhanced MammographyUndergo CESM | Procedure or surgery | Diagnostic (CESM, DBT) |
| Digital Tomosynthesis MammographyAlso: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the BreastUndergo DBT | Procedure or surgery | Diagnostic (CESM, DBT) |
| Iodinated Contrast AgentAlso: Iodinated Contrast Dye, Iodine-containing Contrast MediaGiven iodine-based contrast agent IV | Drug | Diagnostic (CESM, DBT) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (CESM, DBT) |
Primary outcome
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)
Time frame: through study completion, an average of 1 year
Will be compared to low exposure (LE) images of CESM (full field digital mammogram equivalent) in detecting the causative lesion (invasive malignancy, ductal carcinoma in situ (DCIS), atypia, or papilloma) in patients with pathologic nipple discharge (PND).
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 11 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, MD 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 Digital Mammography, Digital Tomosynthesis Mammography and Iodinated Contrast Agent 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 8 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 11 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?
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM) (time frame: through study completion, an average of 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 11 Aug 2026.