Breast CancerPhase 2CESMNCT06311695
Contrast-Enhanced Spectral Mammography (CESM)
A Phase 2 study testing Contrast Enhanced Mammography in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB). 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2020to 31 Dec 2025
- Phase
- Phase 2
- 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
Who may be able to join
- Patients with breast lesions, who underwent bilateral CEM
- Histological assessment
Who cannot join
- The subject is known to have risks of adverse effects with iodine contrast agents
- The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
Milan, 20141
Luca Nicosia, MD
About this study
Official title: The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer
The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).
Read the detailed description
Breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy.
Improvement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages.
The main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings.
The main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. The reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. The sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts.
For this purpose, a diagnostic technique called contrast-enhanced mammography (CEM) has been developed in recent years: CEM is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (FDA).
The diagnostic performance of CEM in detecting and predicting the malignancy of breast lesions has been evaluated in many studies that have shown very promising result: CEM seems to provide excellent performance, particularly where conventional diagnostic methods seem to be struggling: the low sensitivity of mammography in dense breasts; the high operator dependence of breast ultrasound; the high cost, the high number of false positives and the time required to perform Magnetic Resonance Imaging (MRI).
The purpose of this studt is to assess the diagnostic performance of recombined CEM image, in predicting malignancy of breast lesions in a population mainly represented by patients with dense breasts.
- Conditions
- Breast Cancer
- Being tested
- Contrast Enhanced Mammography
- Keywords
- mammography, enhancement, Contrast Enhanced Mammography
- 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 MammographyDevice
Contrast Enhanced Mammography
| Study group | Role | What they receive |
|---|---|---|
| Contrast Enhanced Mammography | Experimental | Patients underwent Contrast Enhanced Mammography Receives: Device: Contrast Enhanced Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of negative predictive value (NPV) of the CEM
Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB. Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM
Measured: 1 month
Secondary outcomes (3)
Evaluation of sensitivity of CEM
Sensitivity will be expressed as the proportion of patients classified as positive with CEM, among all patients with malignant tumors classified with VABB (true positives)
Measured: 1 month
Evaluation of specificity of CEM
Specificity will be expressed as the proportion of patients classified as negative with CEM, among all patients with benign tumors classified with VABB (true negatives)
Measured: 1 month
Positive Predictive Value (PPV) of CEM
The positive predictive value will be expressed as the proportion of patients with malignant tumors classified with VABB among all patients classified as positive with CEM
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start16 Nov 2020
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Dec 2025 (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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Cassano, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311695
- Sponsor's protocol ID
- IEO 960
- Acronym
- CESM
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer
- ClinicalTrials.gov ID
- NCT06311695
- Acronym / sponsor ID
- CESM / IEO 960
- Conditions
- Breast Cancer
- Keywords
- mammography, enhancement, Contrast Enhanced Mammography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Mar 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 study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).
Detailed description
Breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy.
Improvement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages.
The main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings.
The main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. The reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. The sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts.
For this purpose, a diagnostic technique called contrast-enhanced mammography (CEM) has been developed in recent years: CEM is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (FDA).
The diagnostic performance of CEM in detecting and predicting the malignancy of breast lesions has been evaluated in many studies that have shown very promising result: CEM seems to provide excellent performance, particularly where conventional diagnostic methods seem to be struggling: the low sensitivity of mammography in dense breasts; the high operator dependence of breast ultrasound; the high cost, the high number of false positives and the time required to perform Magnetic Resonance Imaging (MRI).
The purpose of this studt is to assess the diagnostic performance of recombined CEM image, in predicting malignancy of breast lesions in a population mainly represented by patients with dense breasts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast Enhanced Mammography | Experimental | Device: Contrast Enhanced MammographyPatients underwent Contrast Enhanced Mammography |
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)
- Patients with breast lesions, who underwent bilateral CEM
- Histological assessment
Key exclusion criteria (2 listed)
- The subject is known to have risks of adverse effects with iodine contrast agents
- The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination
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 MammographyContrast Enhanced Mammography | Device | Contrast Enhanced Mammography |
Primary outcome
Evaluation of negative predictive value (NPV) of the CEM
Time frame: 1 month
Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB. Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM
3 secondary outcomes
Evaluation of sensitivity of CEM
Time frame: 1 month
Evaluation of specificity of CEM
Time frame: 1 month
Positive Predictive Value (PPV) of CEM
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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. This study is not recruiting at the moment.
Enrico Cassano, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contrast Enhanced Mammography in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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 Italy. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Cassano, MD (+390257489410, enrico.cassano@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of negative predictive value (NPV) of the CEM (time frame: 1 month). 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 24 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.