NCT06843096

Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome

Contrast-Enhanced Mammography (CEM) in the Evaluation of Cancer of Unknown Primary Syndrome (CUP): A Multicentric Observational Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Graziella di Grezia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the role of Contrast-Enhanced Mammography (CEM) in identifying the primary tumor site in patients presenting with Cancer of Unknown Primary (CUP) syndrome. By integrating functional and anatomical imaging, the study explores CEM's diagnostic value compared to standard imaging modalities in a single-center setting.

Detailed description

The study of CUP syndrome was conducted with MRI, but we propose the study with CEM

Conditions

• Breast Cancer Diagnosis
• Breast Cancer Prevention

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast-Enhanced Mammography (CEM)	The intervention in this study involves Contrast-Enhanced Mammography (CEM), a specialized imaging technique that combines standard mammography with contrast-enhanced imaging to detect neo-angiogenesis, which is a characteristic of malignancy. Unlike traditional mammography, CEM utilizes both low-energy and high-energy images to provide enhanced visualization of tissue vascularity, aiding in the identification of occult primary tumors, particularly in patients with Cancer of Unknown Primary (CUP) syndrome. Patients who present with CUP syndrome, suspected of having a primary breast malignancy, will undergo CEM as part of their diagnostic workup. The CEM findings will be compared with other conventional imaging modalities, including ultrasound and MRI, to assess the diagnostic accuracy of CEM in detecting primary breast tumors. The intervention will also involve correlating the imaging results with histopathological findings from biopsy or surgical specimens. This study aims to demons

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-01
• Completion: 2026-01-31
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: Italy