Breast CancerNCT05990478
A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial summary
The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast-Enhanced Mammography and Breast MRI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2023to 26 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Potential research subjects will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Who may be able to join
- Any women >18 years of age at time of informed consent
- Diagnosed with breast cancer and schedule for NAT
Who cannot join
- History of kidney disease, creatinine level >1.3 or eGFR <45.
- Known allergic reaction to gadolinium or iodinated contrast media.
- Contraindication to contrast-enhanced breast MRI.
- Lesion not included in the field of view of either pre- or post-NAT MRI or CEM
- Presence of pacemakers or automated implantable cardioverter defibrilator
- Pregnant women
About this study
Official title: Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer
The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.
- Conditions
- Breast Cancer
- Being tested
- Contrast-Enhanced Mammography, Breast MRI
- Keywords
- breast cancer, Memorial Sloan Kettering Cancer Center, 23-224
- 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 MammographyDiagnostic test
Also called CEM
Participants will have pre- and post-treatment CEM of the affected breast
Breast MRIDiagnostic test
Pre- and post-NAT breast MRI will be performed for all participants
| Study group | Role | What they receive |
|---|---|---|
| Participants with Breast Cancer | Participants will have a diagnosis of breast cancer Receives: Diagnostic Test: Contrast-Enhanced Mammography; Diagnostic Test: Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.
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 posted14 Aug 2023
- Study start3 Aug 2023
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Why it stopped: Challenges to participant accrual
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.
- More trials run by Memorial Sloan Kettering 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joao Machado Horvat, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990478
- Sponsor's protocol ID
- 23-224
- Status last verified
- May 2025
- First submitted
- 4 Aug 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05990478
- Acronym / sponsor ID
- 23-224
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Memorial Sloan Kettering Cancer Center, 23-224
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Challenges to participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 14 Aug 2023 (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 find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Breast Cancer | – | Diagnostic Test: Contrast-Enhanced Mammography, Diagnostic Test: Breast MRIParticipants will have a diagnosis of breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Key inclusion criteria (2 listed)
- Any women >18 years of age at time of informed consent
- Diagnosed with breast cancer and schedule for NAT
Key exclusion criteria (6 listed)
- History of kidney disease, creatinine level >1.3 or eGFR <45.
- Known allergic reaction to gadolinium or iodinated contrast media.
- Contraindication to contrast-enhanced breast MRI.
- Lesion not included in the field of view of either pre- or post-NAT MRI or CEM
- Presence of pacemakers or automated implantable cardioverter defibrilator
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: CEMParticipants will have pre- and post-treatment CEM of the affected breast | Diagnostic test | Participants with Breast Cancer |
| Breast MRIPre- and post-NAT breast MRI will be performed for all participants | Diagnostic test | Participants with Breast Cancer |
Primary outcome
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
Time frame: Up to 1 year
compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Joao Machado Horvat, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center.
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 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: withdrawn, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition (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 21 May 2025.