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NCT06843083

Supine Photon-Counting CT and Contrast-Enhanced Mammography Versus Breast MRI for Pretreatment Tumor Size in Breast Cancer Candidates for Neoadjuvant Chemotherapy

Sponsor: Graziella di Grezia

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

17

Start Date

2025-04-01

Completion Date

2026-10-30

Last Updated

2026-11-03

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

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

CEM

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).

DIAGNOSTIC_TEST

Prone dynamic contrast-enhanced breast MRI

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.

Locations (1)

Aou Sassari

Sassari, Italy