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

NCT06843096 | Enrolling By Invitation

• 1 other identifier: T_1_2025
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Diagnosis; Breast Cancer Prevention

Keywords

Contrast-Enhanced Mammography (CEM); Cancer of Unknown Primary (CUP); Breast Cancer; MRI (Magnetic Resonance Imaging); Diagnostic Imaging

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Primary Tumors using Contrast-Enhanced Mammography (CEM) in Patients with CUP Syndrome

  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 Outcomes (2)

• Sensitivity, Specificity, and Diagnostic Accuracy of CEM compared to Standard Imaging Modalities (Ultrasound, MRI, Mammography)

  From enrollment to the end of treatment at 12 months

• Correlation of CEM Findings with Histopathological Results

  From enrollment to the end of treatment at 12 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to cisgender women and transgender women who have breast tissue and are presenting with Cancer of Unknown Primary (CUP) syndrome and suspected primary breast malignancy. Individuals must have mammary tissue to be eligible for participation, as the study involves Contrast-Enhanced Mammography (CEM), which is specifically used to evaluate breast malignancies.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Graziella di Grezia: lead
• Link Campus University: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

Link Campus University

Rome, 80138, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Graziella Di Grezia, medicine and surgery

  Link Campus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 24, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: January 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

IT (1)