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Идёт набор NCT07443579

Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography

Без фазы С лечением Breast Cancer Breast Cancer Recurrence Post Treatment Surveillance

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: Mammography View Sequencing.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Breast Cancer Recurrence, Post Treatment Surveillance. 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
Ирландия
Следующий шаг
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Обзор

This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Women treated with breast-conserving surgery within the previous five years will be randomised 1:1:1:1 to one of four mammography view sequencing groups. The primary objective is to compare patient-reported pain and satisfaction across sequencing groups. Secondary objectives include comparison of image quality (PGMI scoring), compression force, and breast thickness. A total of 400 participants will be enrolled at Beaumont Hospital Breast Care Centre over 2.5 years.

Подробное описание

Women with a history of breast cancer routinely undergo annual surveillance mammography following breast-conserving surgery and radiotherapy. Standard mammography includes mediolateral oblique (MLO) and craniocaudal (CC) views of each breast. However, there is limited evidence regarding whether the order in which these views are obtained affects patient experience or image quality.

This study randomises 400 women (1:1:1:1) to four different view sequencing protocols:

1. Untreated MLO --- Treated MLO --- Untreated CC --- Treated CC 2. Untreated CC --- Treated CC --- Untreated MLO --- Treated MLO 3. Treated MLO --- Untreated MLO --- Treated CC --- Untreated CC 4. Treated CC --- Untreated CC --- Treated MLO --- Untreated MLO

Pain is assessed using a visual analogue scale (VAS) before and after mammography. Patient satisfaction is measured using a post-procedure questionnaire. Image quality will be assessed retrospectively using PGMI scoring by two radiologists. Compression force and breast thickness will also be recorded.

The study uses an intention-to-treat analysis framework.

Вмешательства

  • Процедура Mammography View Sequencing
    Standard surveillance mammography consisting of MLO and CC views of both treated and untreated breasts. Participants are randomised to one of four predefined sequences determining the order in which views are obtained. No additional imaging beyond standard of care is performed.

Первичные конечные точки

  • Change in Patient-Reported Pain Score During Mammography [Срок оценки: Immediately before and immediately after mammography (same study visit)]
  • Patient Satisfaction Following Mammography [Срок оценки: Immediately after mammography (same study visit)]
Вторичные конечные точки (5)
  • Image Quality (PGMI Score) [Срок оценки: Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)]
  • Compression Force During Mammography [Срок оценки: During mammography (same study visit)]
  • Breast Thickness During Mammography [Срок оценки: During mammography (same study visit)]
  • Mean Glandular Radiation Dose [Срок оценки: During mammography (same study visit)]
  • Duration of Mammography Procedure [Срок оценки: During mammography (same study visit)]

Критерии участия

Критерии включения

Female patients aged 18 years or older History of breast cancer treated with breast-conserving surgery (wide local excision) Undergoing first annual surveillance mammogram following completion of surgery and radiotherapy Within five years of breast cancer treatment May have history of whole-breast or partial-breast radiotherapy May have history of axillary surgery Able and willing to provide informed consent

Критерии исключения

Male patients Patients younger than 18 years History of mastectomy History of bilateral wide local excision Lack of capacity to provide informed consent More than five years since completion of breast cancer treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Ирландия · 1 центр
  • Beaumont RCSI Cancer Centre — Beaumont

Идентификаторы

NCT: NCT07443579 · 25-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗