Breast CancerEarly Phase 1NCT06220214
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
A Early Phase 1 study testing CEDM, CEDBT and Omnipaque 350mgI/mL Solution for Injection in people with Breast Cancer and Locally Advanced Breast Cancer, run by Alison Stopeck at 1 site in United States.
Trial summary
The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy
- What is being tested?
- CEDM, CEDBT and Omnipaque 350mgI/mL Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 31 Aug 2026
- Phase
- Early Phase 1
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
- Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery
Who cannot join
- Pregnancy
- Allergy/sensitivity to contrast agent
- Decreased kidney function
- Diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook Breast Center
Stony Brook, New York, 11794
Caterina Vacchi-Suzzi, PhD, 631-216-2993, caterina.vacchi-suzzi@stonybrookmedicine.edu
Hailiang Huang, PhD, Hailiang.Huang@stonybrookmedicine.edu
About this study
Official title: Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.
Participation may last up to 18 weeks.
Read more
Study procedures for this research are:
- Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.
- Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent
- Let the research team record information from your medical record related to your condition and the treatment you receive.
- Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, HER2-positive Breast Cancer, Triple Negative Breast Cancer, TNBC, Triple Negative Breast Cancer
- Being tested
- CEDM, CEDBT, Omnipaque 350mgI/mL Solution for Injection
- Keywords
- cedm, cedbt, contrast-enhanced digital mammography, contrast-enhanced digital breast tomosynthesis, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEDMDiagnostic test
Contrast Enhanced Digital Mammography
CEDBTDiagnostic test
Contrast-Enhanced Digital Breast Tomosynthesis
Omnipaque 350mgI/mL Solution for InjectionDrug
Injection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging.
| Study group | Role | What they receive |
|---|---|---|
| CEDM + CEDBT | Experimental | Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times) Receives: Diagnostic Test: CEDM; Diagnostic Test: CEDBT; Drug: Omnipaque 350mgI/mL Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects
The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast
Measured: Immediately after definitive breast surgery, up to 24 weeks
Secondary outcomes (1)
Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI
Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size
Measured: Immediately before definitive breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start6 Mar 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alison Stopeck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alison Stopeck, Stony Brook University
- Investigators
- Alison Stopeck, MD, Principal investigator, Stony Brook Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220214
- Sponsor's protocol ID
- SBU-BC-NAC-CEDM
- Other IDs
- IRB2023-00508
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06220214
- Acronym / sponsor ID
- SBU-BC-NAC-CEDM
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, HER2-positive Breast Cancer, Triple Negative Breast Cancer, TNBC, Triple Negative Breast Cancer
- Keywords
- cedm, cedbt, contrast-enhanced digital mammography, contrast-enhanced digital breast tomosynthesis, neoadjuvant chemotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alison StopeckUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 23 Jan 2024 (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.
The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.
Participation may last up to 18 weeks.
Study procedures for this research are:
- Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.
- Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent
- Let the research team record information from your medical record related to your condition and the treatment you receive.
- Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEDM + CEDBT | Experimental | Diagnostic Test: CEDM, Diagnostic Test: CEDBT, Drug: Omnipaque 350mgI/mL Solution for InjectionParticipants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
- Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery
Key exclusion criteria (4 listed)
- Pregnancy
- Allergy/sensitivity to contrast agent
- Decreased kidney function
- Diabetes
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 |
|---|---|---|
| CEDMContrast Enhanced Digital Mammography | Diagnostic test | CEDM + CEDBT |
| CEDBTContrast-Enhanced Digital Breast Tomosynthesis | Diagnostic test | CEDM + CEDBT |
| Omnipaque 350mgI/mL Solution for InjectionInjection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging. | Drug | CEDM + CEDBT |
Primary outcome
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects
Time frame: Immediately after definitive breast surgery, up to 24 weeks
The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast
1 secondary outcome
Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI
Time frame: Immediately before definitive breast surgery
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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Alison Stopeck, MD principal investigator
Stony Brook Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CEDM, CEDBT and Omnipaque 350mgI/mL Solution for Injection in people with Breast Cancer and Locally Advanced Breast Cancer, run by Alison Stopeck 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 2 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: looking for participants now, as of the sponsor's last update on 15 Jan 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alison Stopeck, MD (631-444-7217, alison.stopeck@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects (time frame: Immediately after definitive breast surgery, up to 24 weeks). 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 15 Jan 2026.