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Набор скоро начнётся NCT07277738

Precision Supplemental Imaging in Women With Dense Breasts

Без фазы С лечением Breast Cancer Cancer of the Breast

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: Prognosia Breast, Mammogram, MRI.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Cancer of the Breast. Базовые параметры: 25 лет — 55 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
США
Следующий шаг
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Официальное название

Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)

Обзор

Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.

Вмешательства

  • Устройство Prognosia Breast
    The risk output from this algorithm is calibrated to US Surveillance, Epidemiology, and End Results (SEER) 5-year risk and so estimates for each woman the personal 5-year risk.
  • Устройство Mammogram
    Standard of care annual screening mammogram
  • Устройство MRI
    MRI at the time of annual screening mammogram

Первичные конечные точки

  • Number of successful recommendations for MRI (Feasibility portion only) [Срок оценки: Through completion of follow-up (estimated to be 24 months)]
  • 2-year detection rate (Randomized Controlled Trial only) [Срок оценки: 2 years]
Вторичные конечные точки (5)
  • Sample size for randomized controlled trial (Feasibility portion only) [Срок оценки: Through completion of follow-up (estimated to be 24 months)]
  • Number and percentage of recalls (Feasibility portion only) [Срок оценки: Through completion of follow-up (estimated to be 24 months)]
  • Positive predictive value for recall for additional testing and biopsy (Feasibility portion only) [Срок оценки: Through completion of follow-up (estimated to be 24 months)]
  • Number and percentage of recalls (Randomized Controlled Trial only) [Срок оценки: Through completion of follow-up (estimated to be 24 months)]
  • Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only) [Срок оценки: Through completion of follow-up (estimated to be 24 months)]

Критерии участия

Критерии включения

  • Normal screening mammogram within 90 days prior to enrollment.
  • Dense breasts, either:
  • Class C density ("the breasts are heterogeneously dense, which may obscure small masses")
  • Class D density ("the breasts are extremely dense, which lowers the sensitivity of mammography")
  • MRS risk estimate at > 3% 5-year risk of breast cancer.
  • Female.
  • Between 25 and 55 years of age (inclusive).
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Критерии исключения

  • More than 1 prior mammogram
  • Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity/allergy to gadolinium).
  • Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
  • Prior MRI screening of the breast.
  • Known to be BRCA 1/2 positive or presence of any other known high penetrance genetic marker.
  • Is receiving any chemoprevention.
  • Has breast implants.
  • Is breastfeeding.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07277738 · 202511123

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗