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

• Conditions: Breast Cancer Diagnosis; Breast Cancer Prevention

• Registration Number: NCT06843096
• Lead Sponsor: Graziella di Grezia

Brief 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

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-03-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Age: Patients aged 18 years or older.
• Diagnosis of CUP: Patients with a clinical diagnosis of Cancer of Unknown Primary (CUP) syndrome.
• Suspected Breast Malignancy: Patients with clinical or imaging suspicion of a primary breast malignancy.
• Informed Consent: Patients who are able to provide informed consent to participate in the study.
• Presence of Breast Tissue: Female or transgender patients with breast tissue eligible for Contrast-Enhanced Mammography (CEM).

Exclusion Criteria

• Confirmed Primary Tumor: Patients with a confirmed primary tumor identified in an organ other than the breast.
• Contraindications to Contrast Agents: Patients with contraindications to the use of iodinated contrast agents (e.g., severe allergic reactions to contrast).
• Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) who cannot safely receive contrast agents.
• Pregnancy or Breastfeeding: Pregnant or breastfeeding women, as contrast administration may be harmful to the fetus or neonate.
• Severe Medical Conditions: Patients with severe medical conditions that may compromise their participation or safety in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection Rate of Primary Tumors using Contrast-Enhanced Mammography (CEM) in Patients with CUP Syndrome	From enrollment to the end of treatment at 12 months	The primary outcome of this study is the detection rate of primary tumors in patients presenting with Cancer of Unknown Primary (CUP) syndrome using Contrast-Enhanced Mammography (CEM). The detection rate will be determined by comparing the CEM findings with histopathological results from biopsies or surgical specimens. This will allow us to assess the diagnostic accuracy of CEM in identifying occult primary tumors, particularly in the context of breast cancer.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, Specificity, and Diagnostic Accuracy of CEM compared to Standard Imaging Modalities (Ultrasound, MRI, Mammography)	From enrollment to the end of treatment at 12 months	This secondary outcome aims to evaluate the sensitivity, specificity, and diagnostic accuracy of CEM in detecting primary tumors compared to other conventional imaging techniques, including ultrasound, MRI, and standard mammography. These metrics will be analyzed to determine the relative effectiveness of CEM as a diagnostic tool.
Correlation of CEM Findings with Histopathological Results	From enrollment to the end of treatment at 12 months	This measure aims to correlate the CEM findings with the histopathological results from biopsy or surgical specimens. This will assess how well the CEM images match the final diagnosis of primary tumors based on tissue analysis.

Trial Locations

Locations (1)

Link Campus University; 🇮🇹 Rome, Italy