Breast Cancer DiagnosisNCT06846814
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
An observational study of Breast Cancer Diagnosis and Breast Cancer Detection, run by Graziella di Grezia at 1 site in Italy.
Trial summary
This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Diagnosis, Breast Cancer Detection
- What is being tested?
- CEM protocol
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2022to 30 Jun 2026
- 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: Women aged 18 years and older undergoing CEM as part of diagnostic or surveillance protocols. Lesions detected by CEM that require additional characterization.
Who may be able to join
- Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes.
- Identification of additional lesions on CEM requiring further evaluation.
- Ability to provide informed consent.
Who cannot join
- Known breast cancer diagnosis without suspicion of additional lesions.
- Contraindications to ultrasound or contrast agents.
- Patients with incomplete imaging data.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.
Read the detailed description
The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.
- Conditions
- Breast Cancer Diagnosis, Breast Cancer Detection
- Being tested
- CEM protocol
- Keywords
- Second look ultrasound, contrast enhanced mammography, breast cancer detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEM protocolDiagnostic test
The intervention consists of Second-Look Ultrasound (SLUS) performed following Contrast-Enhanced Mammography (CEM) to further evaluate additional lesions detected during routine breast imaging.
When CEM identifies additional or suspicious lesions not clearly characterized by mammography alone, targeted ultrasound is conducted to assess lesion morphology, vascularity, and acoustic characteristics. Radiologists with expertise in both CEM and ultrasound interpretation will perform SLUS to determine whether the lesions require biopsy, short-term follow-up, or no further action. Findings will be correlated with histopathological results (if biopsy is performed) or follow-up imaging to assess diagnostic accuracy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rate of Additional Lesions on CEM
This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy.
Measured: Within 12 months of imaging assessment.
Secondary outcomes (2)
Concordance Between Imaging Findings and Histopathology
This measure assesses the percentage of biopsied lesions in which imaging findings (from CEM and SLUS) correlate with the histopathological results
Measured: Up to 3 months post-biopsy.
Concordance Between Imaging Findings and Follow-Up Imaging
This measure evaluates the percentage of lesions that remain stable or resolve in follow-up imaging, confirming or refuting the initial CEM and ultrasound findings.
Measured: 6-12 months after the initial CEM examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 May 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer DiagnosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graziella di Grezia
- Sponsor type
- University, hospital or other
- Collaborators
- Link Campus University, University of Campania Luigi Vanvitelli
- Responsible party
- Sponsor-investigator, Graziella di Grezia, Link Campus University
- Investigators
- Graziella Di Grezia, Medicine, Principal investigator, Link Campus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846814
- Sponsor's protocol ID
- T_4_2025
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Grezia G, Mercogliano S, Marinelli L, Nazzaro A, Galiano A, Cisternino E, Gatta G, Cuccurullo V, Scaglione M. Contrast-Enhanced Mammography in Breast Lesion Assessment: Accuracy and Surgical Impact. Tomography. 2025 Aug 20;11(8):93. doi: 10.3390/tomography11080093.
PubMed 40863884
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
- ClinicalTrials.gov ID
- NCT06846814
- Acronym / sponsor ID
- T_4_2025
- Conditions
- Breast Cancer Diagnosis, Breast Cancer Detection
- Keywords
- Second look ultrasound, contrast enhanced mammography, breast cancer detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Graziella di GreziaUniversity, hospital or other
- Collaborators
- Link Campus University, University of Campania Luigi Vanvitelli
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 26 Feb 2025 (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 study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.
Detailed description
The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 years and older undergoing CEM as part of diagnostic or surveillance protocols. Lesions detected by CEM that require additional characterization.
Key inclusion criteria (3 listed)
- Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes.
- Identification of additional lesions on CEM requiring further evaluation.
- Ability to provide informed consent.
Key exclusion criteria (3 listed)
- Known breast cancer diagnosis without suspicion of additional lesions.
- Contraindications to ultrasound or contrast agents.
- Patients with incomplete imaging data.
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 |
|---|---|---|
| CEM protocolThe intervention consists of Second-Look Ultrasound (SLUS) performed following Contrast-Enhanced Mammography (CEM) to further evaluate additional lesions detected during routine breast imaging. When CEM identifies additional or suspicious lesions not clearly characterized by mammography alone, targeted ultrasound is conducted to assess lesion morphology, vascularity, and acoustic characteristics. Radiologists with expertise in both CEM and ultrasound interpretation will perform SLUS to determine whether the lesions require biopsy, short-term follow-up, or no further action. Findings will be correlated with histopathological results (if biopsy is performed) or follow-up imaging to assess diagnostic accuracy. | Diagnostic test | – |
Primary outcome
Detection Rate of Additional Lesions on CEM
Time frame: Within 12 months of imaging assessment.
This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy.
2 secondary outcomes
Concordance Between Imaging Findings and Histopathology
Time frame: Up to 3 months post-biopsy.
Concordance Between Imaging Findings and Follow-Up Imaging
Time frame: 6-12 months after the initial CEM examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 40863884Di Grezia G, Mercogliano S, Marinelli L, Nazzaro A, Galiano A, Cisternino E, Gatta G, Cuccurullo V, Scaglione M. Contrast-Enhanced Mammography in Breast Lesion Assessment: Accuracy and Surgical Impact. Tomography. 2025 Aug 20;11(8):93. doi: 10.3390/tomography11080093.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Diagnosis
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Graziella Di Grezia, Medicine principal investigator
Link Campus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Diagnosis and Breast Cancer Detection, run by Graziella di Grezia 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 3 inclusion and 3 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 2 Nov 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection Rate of Additional Lesions on CEM (time frame: Within 12 months of imaging assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846814, which also lists 1 linked publication.
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 2 Nov 2026.