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Набор скоро начнётся NCT06854887

The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

— Наблюдательное Digital Breast Tomosynthesis

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: digital breast tomosynthesis and mammography.
Кому может быть актуально
Состояния в реестре: Digital Breast Tomosynthesis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Added Value of Digital Breast Tomosynthesis Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

Обзор

Compare the diagnostic accuracy of tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 to determine its potential benefit for staging

Подробное описание

Digital breast tomosynthesis (DBT) is a promising 3D imaging technique for breast imaging that use in breast cancer detection. it acquires reconstructed volume data , the data is reconstructed secondarily in mammary slices from several radiographs acquired from different angles of view (-15◦ to +15◦ for Fuji). It theoretically improves the sensitivity of detection by enabling enhanced delimitation of the lesion margins, and the specificity by avoiding the problem of glandular superimposition, By separating overlapping breast tissues \& it enhances detection of abnormalities located in different planes. DBT has higher breast cancer detection rates and lower recall rates compared with digital mammography (DM). There is also evidence of the diagnostic efficacy of DBT in women with clinical symptoms and women with screen-detected findings who have been recalled for work-up. Consequently, recommendations have been made about the role of DBT in screening asymptomatic women according to their risk levels, in evaluation of symptomatic women, and in work-up of suspicious DM findings. The main objective of this study was to compare tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 anomalies, to determine its potential benefit for staging.

Вмешательства

  • Устройство digital breast tomosynthesis and mammography
    tomosynthesis is 3D image for the breast mammography is 2D image for the breast

Первичные конечные точки

  • Recording The breast density in both tomosynthesis and mammography for the main and satellite lesions [Срок оценки: baseline]
  • Recording the type of lesion in both tomosynthesis and mammography for the main and satellite lesions [Срок оценки: baseline]
  • Recording the probability of multifocality or multicentricity in both tomosynthesis and mammography for the main and satellite lesions [Срок оценки: baseline]
  • Recording the location of the tumor within the mammary quadrants and the depth of the tumor in both tomosynthesis and mammography for the main and satellite lesions [Срок оценки: baseline]
  • Recording the tumor histopathology type for the main and satellite lesions [Срок оценки: baseline]

Критерии участия

Критерии включения

  • BI-RADS 4 OR 5 LESION that pathologically proved to be breast cancer.
  • No history of previous operations
  • No history of chemotherapy or radiotherapy

Критерии исключения

  • BI-RADS 1 ,2,3 lesions
  • History of previous operation

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Mariscotti G, Durando M, Houssami N, Fasciano M, Tagliafico A, Bosco D, Casella C, Bogetti C, Bergamasco L, Fonio P, Gandini G. Comparison of synthetic mammography, reconstructed from digital breast tomosynthesis, and digital mammography: evaluation of lesion conspicuity and BI-RADS assessment categories. Breast Cancer Res Treat. 2017 Dec;166(3):765-773. doi: 10.1007/s10549-017-4458-3. Epub 2017 A PMID 28819781
  • Bernardi D, Belli P, Benelli E, Brancato B, Bucchi L, Calabrese M, Carbonaro LA, Caumo F, Cavallo-Marincola B, Clauser P, Fedato C, Frigerio A, Galli V, Giordano L, Giorgi Rossi P, Golinelli P, Morrone D, Mariscotti G, Martincich L, Montemezzi S, Naldoni C, Paduos A, Panizza P, Pediconi F, Querci F, Rizzo A, Saguatti G, Tagliafico A, Trimboli RM, Zappa M, Zuiani C, Sardanelli F. Digital breast tom PMID 28540564
  • Marinovich ML, Hunter KE, Macaskill P, Houssami N. Breast Cancer Screening Using Tomosynthesis or Mammography: A Meta-analysis of Cancer Detection and Recall. J Natl Cancer Inst. 2018 Sep 1;110(9):942-949. doi: 10.1093/jnci/djy121. PMID 30107542

Идентификаторы

NCT: NCT06854887 · DBT &Mammography in BIRADS 4-5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗