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Идёт набор NCT06105749

Biennial CEM in Women With a Personal History of Breast Cancer

Без фазы С лечением Breast Cancer Breast Neoplasms Breast Cancer Female Neoplasms

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: contrast-enhanced mammography.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Breast Neoplasms, Breast Cancer Female, Neoplasms. Базовые параметры: 30 лет — 79 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

Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)

Обзор

This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.

Подробное описание

The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).

Вмешательства

  • Устройство contrast-enhanced mammography
    Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.

Первичные конечные точки

  • Incremental Cancer Detection Rate [Срок оценки: at 24 months, 48 months, and 62 months]
  • False-positive recall rate [Срок оценки: at 24 months, 48 months, and 62 months]
  • Positive-predictive values [Срок оценки: at 24 months, 48 months, and 62 months]

Критерии участия

Критерии включения

  • Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).

Критерии исключения

  • Women with a history of prior moderate or severe iodinated contrast reaction \[only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded\].
  • Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions.
  • Women who have had bilateral mastectomy
  • Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 45 mL/min
  • Pregnancy or lactation
  • Women actively being treated for cancer of any type with chemotherapy
  • Having only one kidney
  • Women with stage 4 metastasis to visceral areas or brain
  • Women who have a screening breast MRI exam within 24 months prior to the current round of CEM.
  • Women who had a CEM exam within the prior 23 months

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 6 центров
  • UPMC Magee-Womens Imaging - Bethel Park — Bethel Park
  • UPMC Magee at the Lemieux Sports Complex — Cranberry Township
  • Magee Womancare Monroeville — Monroeville
  • Magee-Womens Hospital — Pittsburgh
  • Hillman Cancer Center at Shadyside — Pittsburgh
  • UPMC West Mifflin Outpatient Center — West Mifflin

Идентификаторы

NCT: NCT06105749 · STUDY23080183

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗