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Clinical Trials in Italy / NCT06843096
Enrolling by invitation Observational

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

NCT06843096 · tracked via the Priya Life Science Italy tracker
Sponsor
Graziella di Grezia
Phase
Observational
Started
2025-01-01
Last updated
2025-02-24

Condition(s) studied

Breast Cancer DiagnosisBreast Cancer Prevention

Investigational drug(s) / intervention(s)

Contrast-Enhanced Mammography (CEM)

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Link Campus University Rome Italy

More Graziella di Grezia trials in Italy

From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System Enrolling by invitation
Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance? Enrolling by invitation
DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue Enrolling by invitation
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization Enrolling by invitation

Other trials for the same condition

Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance? Enrolling by invitation
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06843096 on ClinicalTrials.gov ↗ ← All trials in Italy