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Набор по приглашению NCT06843083

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

— Наблюдательное Breast Cancer Prevention Breast Cancer Diagnosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CEM protocol, breast MRI.
Кому может быть актуально
Состояния в реестре: Breast Cancer Prevention, Breast Cancer Diagnosis. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Contrast-Enhanced Mammography or Breast MRI: Which Choice for Optimal Diagnostic Performance?

Обзор

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.

Подробное описание

Search differences and performance of MRI and CEM

Вмешательства

  • Диагностический тест CEM protocol
    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.
  • Диагностический тест breast MRI
    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.

Первичные конечные точки

  • Diagnostic Accuracy of CEM vs. MRI for Breast Lesion Detection and Characterization [Срок оценки: From enrollment to the end of treatment at 12 months]
Вторичные конечные точки (3)
  • Sensitivity and Specificity of CEM vs. MRI [Срок оценки: From enrollment to the end of treatment at 12 months]
  • Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of CEM vs. MRI [Срок оценки: From enrollment to the end of treatment at 12 months]
  • Patient Preference and Tolerability of CEM vs. MRI [Срок оценки: From enrollment to the end of treatment at 12 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University of Campania Luigi Vanvitelli — Naples

Идентификаторы

NCT: NCT06843083 · T_2_2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗