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Enrolling by Invitation

NCT Number: NCT06843083

Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance?

This study compares the diagnostic performance of Contrast-Enhanced Mammography (CEM) and Breast MRI in evaluating breast lesions. It aims to assess sensitivity, specificity, and diagnostic accuracy to identify the optimal imaging modality for clinical scenarios such as dense breast tissue and high-risk populations.

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Key information

Conditions

Breast Cancer Prevention Breast Cancer Diagnosis 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

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

About this study

Search differences and performance of MRI and CEM

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: Women aged 18 years and older.
  • Indication for Advanced Imaging: Patients referred for Contrast-Enhanced Mammography (CEM) or Breast MRI due to suspicious findings or high-risk factors for breast cancer.
  • Dense Breast Tissue or Inconclusive Findings: Patients with dense breast tissue or inconclusive results from standard mammography.

Informed Consent: Ability to provide written informed consent for participation in the study.

  • Presence of Breast Tissue: Female or transgender women who have breast tissue suitable for imaging.

Exclusion criteria

  • Contraindications to MRI: Patients with contraindications to Breast MRI (e.g., implanted pacemakers, severe claustrophobia, or metallic implants that cannot be removed).
  • Contraindications to Contrast Agents: Patients who have allergies or contraindications to iodinated contrast agents used in CEM.

Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), as they may not safely undergo contrast-enhanced imaging.

  • Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding, as the use of contrast agents may pose risks to the fetus or infant.
  • Already Confirmed Primary Tumor: Patients with a confirmed primary breast malignancy or another primary tumor site (e.g., gastrointestinal, lung) that has already been diagnosed.
  • Other Medical Conditions: Patients with serious medical conditions that may interfere with participation in the study or may affect the safety of the imaging procedures.

Treatment and study plan

CEM protocol

Diagnostic Test

CEM combines low-energy mammography with high-energy contrast-enhanced imaging to highlight areas of neo-angiogenesis, which are indicative of malignancy. This intervention will be used to evaluate the diagnostic performance of CEM in detecting and characterizing breast lesions, especially in patients with dense breast tissue or inconclusive findings from routine mammography.

Other names: CEM

Breast MRI

Diagnostic Test

MRI (Magnetic Resonance Imaging):

MRI will be used as an alternative imaging modality for breast lesion detection and characterization. MRI provides detailed soft tissue imaging and is widely used in the evaluation of high-risk patients or those with dense breast tissue. The results from MRI will be compared to CEM findings to determine which modality offers superior diagnostic accuracy and clinical impact.

Primary outcomes

  1. Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization

    Time frame: From enrollment to the end of treatment at 12 months

    The primary outcome of the study is to compare the diagnostic accuracy of Contrast-Enhanced Mammography (CEM) and Breast Magnetic Resonance Imaging (MRI) in detecting and characterizing breast lesions. This will be assessed by evaluating the sensitivity, specificity, and overall diagnostic performance of both imaging modalities. Findings will be correlated with histopathological results or follow-up imaging to determine the accuracy of each modality in the diagnosis of breast cancer.

Secondary outcomes

  1. Sensitivity and Specificity of CEM vs. MRI

    Time frame: From enrollment to the end of treatment at 12 months

    This secondary outcome aims to compare the sensitivity and specificity of CEM and MRI in detecting breast lesions. Sensitivity refers to the ability to correctly identify true positives, while specificity refers to correctly identifying true negatives. These metrics will be analyzed to assess the diagnostic capability of each imaging technique.

  2. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of CEM vs. MRI

    Time frame: From enrollment to the end of treatment at 12 months

    The positive predictive value (PPV) and negative predictive value (NPV) will be calculated for both CEM and MRI. PPV indicates the proportion of positive test results that are true positives, while NPV indicates the proportion of negative test results that are true negatives.

  3. Patient Preference and Tolerability of CEM vs. MRI

    Time frame: From enrollment to the end of treatment at 12 months

    This outcome will assess patient preference and tolerability between CEM and MRI. Patients will be asked to complete a questionnaire regarding their comfort during each imaging procedure, and their preference for one modality over the other will be recorded.

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 or Breast MRI: Which Choice for Optimal Diagnostic Performance?

Acronym: CEM MRI choice

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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