Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome (CEM_CUP_syndr)

Graziella di Grezia

Status: Invitation-only

Conditions: Breast Cancer Prevention; Breast Cancer Diagnosis

Treatments: Diagnostic Test: Contrast-Enhanced Mammography (CEM)

Study type: Observational

Funder types: Other

Identifiers

NCT06843096

T_1_2025

Details and patient eligibility

About

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.

Full description

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

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.