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Enrolling by invitation NCT06843096

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

— Observational Breast Cancer Diagnosis Breast Cancer Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contrast-Enhanced Mammography (CEM).
Who it may be relevant to
Registry conditions: Breast Cancer Diagnosis, Breast Cancer Prevention. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Detection Rate of Primary Tumors using Contrast-Enhanced Mammography (CEM) in Patients with CUP Syndrome [Time frame: From enrollment to the end of treatment at 12 months]
Secondary outcome measures (2)
  • Sensitivity, Specificity, and Diagnostic Accuracy of CEM compared to Standard Imaging Modalities (Ultrasound, MRI, Mammography) [Time frame: From enrollment to the end of treatment at 12 months]
  • Correlation of CEM Findings with Histopathological Results [Time frame: From enrollment to the end of treatment at 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Link Campus University — Rome

Identifiers

NCT: NCT06843096 · T_1_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗