Breast Cancer PreventionPC CEM MRINCT06843083
Supine Photon-Counting CT and Contrast-Enhanced Mammography Versus Breast MRI for Pretreatment Tumor Size in Breast Cancer Candidates for Neoadjuvant Chemotherapy
An observational study of Breast Cancer Prevention and Breast Cancer Diagnosis, run by Graziella di Grezia at 1 site in Italy.
Trial summary
Retrospective single-centre agreement study in women with biopsy-proven invasive breast cancer who underwent CEM, supine PC-CT and prone breast MRI before neoadjuvant chemotherapy. Prone MRI is the clinical reference. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention, Breast Cancer Diagnosis
- What is being tested?
- Supine photon-counting CT (PC-CT), CEM and Prone dynamic contrast-enhanced breast MRI
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 30 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive women with biopsy-proven invasive breast cancer referred for NAC to the Department of Radiological, Interventional and Emergency Sciences, Azienda Ospedaliero-Universitaria di Sassari, Italy, between April 2025 and June 2026.
Inclusion Criteria: (a) invasive carcinoma at core needle or vacuum-assisted biopsy; (b) indication for NAC by the multidisciplinary tumor board; (c) CEM, supine PC-CT and breast MRI all performed before NAC.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective single-centre agreement study in women with biopsy-proven invasive breast cancer who underwent CEM, supine PC-CT and prone breast MRI before neoadjuvant chemotherapy. Prone MRI is the clinical reference.
Read the detailed description
Breast MRI is the reference imaging test for locoregional staging but is not available to every patient before NAC. PC-CT performed for systemic staging also images both breasts and axillae. Consecutive women who underwent CEM, supine PC-CT and breast MRI before the first NAC cycle were analyzed. Two breast radiologists reviewed each modality in separate sessions. Because all patients received NAC, surgical pathology could not serve as reference for pretreatment size, so prone dynamic MRI was used as the clinical reference and the study was designed as an agreement study, not a diagnostic accuracy study
- Conditions
- Breast Cancer Prevention, Breast Cancer Diagnosis
- Being tested
- Supine photon-counting CT (PC-CT), CEM, Prone dynamic contrast-enhanced breast MRI
- Keywords
- contrast enhanced mammography, breast MRI, breast cancer, Photon Counting CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine photon-counting CT (PC-CT)Diagnostic test
Clinically indicated contrast-enhanced oncologic staging CT of chest and abdomen, performed in the supine position on a dual-source photon-counting detector CT scanner (NAEOTOM Alpha, Siemens Healthineers). Iodinated contrast medium (370 mg I/mL; 1.2 mL/kg) at 3.5 mL/s, acquisition at a fixed delay of 65-70 s. Breast assessment used the chest portion of the acquisition, with no additional radiation exposure or contrast administration. 40-keV and 60-keV virtual monoenergetic images and iodine maps were reconstructed.
CEMDiagnostic test
Performed on a digital breast tomosynthesis system with CEM capability (3Dimensions, Hologic), with low- and high-energy craniocaudal and mediolateral oblique views after intravenous injection of iodinated contrast medium (1.5 mL/kg).
Prone dynamic contrast-enhanced breast MRIDiagnostic test
Performed in the prone position on a 1.5-T scanner (MAGNETOM Altea, Siemens Healthineers) with a dedicated breast coil, including T2-weighted and multiphase T1-weighted sequences before and after gadolinium-based contrast administration. Used as the clinical reference for tumor size.
| Study group | Role | What they receive |
|---|---|---|
| NAC candidates with three imaging examinations | Women with biopsy-proven invasive breast cancer and indication for NAC who underwent all three examinations before the first NAC cycle. Receives: Diagnostic Test: Supine photon-counting CT (PC-CT); Diagnostic Test: CEM; Diagnostic Test: Prone dynamic contrast-enhanced breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in maximum tumor diameter between supine PC-CT and prone MRI
Bland-Altman mean bias and 95% limits of agreement, and intraclass correlation coefficient, of the maximum diameter of the index cancer.
Measured: before the first NAC cycle (April 2025 to June 2026)
Secondary outcomes (1)
CEM vs MRI e PC-CT vs CEM
Proportion of measurements within ±5 mm and ±20% of MRI size
Measured: before the first NAC cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2026
- Study completion30 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graziella di Grezia
- Sponsor type
- University, hospital or other
- Collaborators
- Link Campus University, Azienda Ospedaliero Universitaria di Sassari
- Responsible party
- Sponsor-investigator, Graziella di Grezia, Link Campus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843083
- Sponsor's protocol ID
- T_2_2025
- Acronym
- PC CEM MRI
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2025
- Last updated
- 3 Nov 2026
- Results posted
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supine Photon-Counting CT and Contrast-Enhanced Mammography Versus Breast MRI for Pretreatment Tumor Size in Breast Cancer Candidates for Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06843083
- Acronym / sponsor ID
- PC CEM MRI / T_2_2025
- Conditions
- Breast Cancer Prevention, Breast Cancer Diagnosis
- Keywords
- contrast enhanced mammography, breast MRI, breast cancer, Photon Counting CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Graziella di GreziaUniversity, hospital or other
- Collaborators
- Link Campus University, Azienda Ospedaliero Universitaria di Sassari
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Oct 2026 (actual)
- First posted
- 24 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.
Retrospective single-centre agreement study in women with biopsy-proven invasive breast cancer who underwent CEM, supine PC-CT and prone breast MRI before neoadjuvant chemotherapy. Prone MRI is the clinical reference.
Detailed description
Breast MRI is the reference imaging test for locoregional staging but is not available to every patient before NAC. PC-CT performed for systemic staging also images both breasts and axillae. Consecutive women who underwent CEM, supine PC-CT and breast MRI before the first NAC cycle were analyzed. Two breast radiologists reviewed each modality in separate sessions. Because all patients received NAC, surgical pathology could not serve as reference for pretreatment size, so prone dynamic MRI was used as the clinical reference and the study was designed as an agreement study, not a diagnostic accuracy study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAC candidates with three imaging examinations | – | Diagnostic Test: Supine photon-counting CT (PC-CT), Diagnostic Test: CEM, Diagnostic Test: Prone dynamic contrast-enhanced breast MRIWomen with biopsy-proven invasive breast cancer and indication for NAC who underwent all three examinations before the first NAC cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive women with biopsy-proven invasive breast cancer referred for NAC to the Department of Radiological, Interventional and Emergency Sciences, Azienda Ospedaliero-Universitaria di Sassari, Italy, between April 2025 and June 2026.
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 |
|---|---|---|
| Supine photon-counting CT (PC-CT)Clinically indicated contrast-enhanced oncologic staging CT of chest and abdomen, performed in the supine position on a dual-source photon-counting detector CT scanner (NAEOTOM Alpha, Siemens Healthineers). Iodinated contrast medium (370 mg I/mL; 1.2 mL/kg) at 3.5 mL/s, acquisition at a fixed delay of 65-70 s. Breast assessment used the chest portion of the acquisition, with no additional radiation exposure or contrast administration. 40-keV and 60-keV virtual monoenergetic images and iodine maps were reconstructed. | Diagnostic test | NAC candidates with three imaging examinations |
| CEMPerformed on a digital breast tomosynthesis system with CEM capability (3Dimensions, Hologic), with low- and high-energy craniocaudal and mediolateral oblique views after intravenous injection of iodinated contrast medium (1.5 mL/kg). | Diagnostic test | NAC candidates with three imaging examinations |
| Prone dynamic contrast-enhanced breast MRIPerformed in the prone position on a 1.5-T scanner (MAGNETOM Altea, Siemens Healthineers) with a dedicated breast coil, including T2-weighted and multiphase T1-weighted sequences before and after gadolinium-based contrast administration. Used as the clinical reference for tumor size. | Diagnostic test | NAC candidates with three imaging examinations |
Primary outcome
Agreement in maximum tumor diameter between supine PC-CT and prone MRI
Time frame: before the first NAC cycle (April 2025 to June 2026)
Bland-Altman mean bias and 95% limits of agreement, and intraclass correlation coefficient, of the maximum diameter of the index cancer.
1 secondary outcome
CEM vs MRI e PC-CT vs CEM
Time frame: before the first NAC cycle.
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 3 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Prevention and Breast Cancer Diagnosis, 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?
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 3 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?
Agreement in maximum tumor diameter between supine PC-CT and prone MRI (time frame: before the first NAC cycle (April 2025 to June 2026)). 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 3 Nov 2026.