Clinical trial NCT06843083: Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance?
Official title: Contrast-Enhanced Mammography or Breast MRI: Which Choice for Optimal Diagnostic Performance?
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer Prevention
Breast Cancer Diagnosis
Keywords: contrast enhanced mammography
breast MRI
breast cancer
Lead sponsor: Link Campus University
Sponsor class: OTHER
Collaborators: name: Link Campus University
name: University of Campania Luigi Vanvitelli
First posted: 2025-02-24
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult women aged 18 years or older who are referred for advanced breast imaging due to suspicious breast lesions or high-risk factors for breast cancer. The population will include individuals with dense breast tissue or those who have had inconclusive findings from standard mammography, making them candidates for Contrast-Enhanced Mammography (CEM) or Breast Magnetic Resonance Imaging (MRI).

The study aims to include a diverse cohort of patients, both in terms of age and background, as long as they meet the inclusion criteria and do not fall under the exclusion criteria. The study will be conducted at ASL Avellino, Italy, and will involve patients from various risk groups, including those with a family history of breast cancer, personal history of other cancers, and those with dense breast tissue who may require advanced imaging for accurate diagnosis.

Brief summary: 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.

Detailed description: Search differences and performance of MRI and CEM

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Sensitivity and Specificity of CEM vs. MRI
timeFrame: From enrollment to the end of treatment at 12 months
measure: Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of CEM vs. MRI
timeFrame: From enrollment to the end of treatment at 12 months
measure: Patient Preference and Tolerability of CEM vs. MRI
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References: