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Enrolling by Invitation

NCT Number: NCT06843096

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

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.

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Key information

Conditions

Breast Cancer Diagnosis Breast Cancer Prevention Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Link Campus University

Rome, 80138, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contrast-Enhanced Mammography (CEM)

Diagnostic Test

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

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. Correlation of CEM Findings with Histopathological Results

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Graziella di Grezia

Other

Collaborators

  • Link Campus University
  • University of Campania Luigi Vanvitelli

Registry information

Official study title

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

Acronym: CEM_CUP_syndr

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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