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

February 19, 2025 updated by: Graziella di Grezia

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 80138
        • Link Campus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients (aged 18 years and older) who are diagnosed with Cancer of Unknown Primary (CUP) syndrome and are suspected of having a primary breast malignancy based on clinical presentation or imaging findings. Eligible patients will have breast tissue suitable for Contrast-Enhanced Mammography (CEM) and will undergo CEM as part of their diagnostic workup to evaluate the potential primary tumor site.

The population will be diverse in terms of age, race, and ethnic backgrounds, provided they meet the inclusion criteria and do not fall under any of the exclusion criteria listed.

The study aims to include a cohort of patients with different stages of CUP syndrome to evaluate the effectiveness of CEM in identifying hidden primary tumors and its impact on clinical management and treatment decisions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Graziella di Grezia

Collaborators

Link Campus University
University of Campania Luigi Vanvitelli

Investigators

  • Principal Investigator: Graziella Di Grezia, Medicine and Surgery, Link Campus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T_1_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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