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Идёт набор NCT07711847

Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy

Без фазы С лечением Invasive Breast Cancer Early Stages Ductal Carcinoma In Situ, DCIS

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: VENUS SHELL™ immobilization device.
Кому может быть актуально
Состояния в реестре: Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS. Базовые параметры: от 40 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

Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery

Обзор

The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on her stomach). The main goals of the study are: * To confirm that using the VENUS SHELL™ is safe and effective * To assess whether the VENUS SHELL™ helps deliver accurate radiation treatment in a faster and more comfortable way Participants will: * Attend a study visit before radiotherapy to have a breast surface scan (no radiation) and enable the production of their personalized VENUS SHELL™ * Use their VENUS SHELL™ during radiotherapy planning and treatment * Be asked to complete questionnaires about their comfort

Вмешательства

  • Устройство VENUS SHELL™ immobilization device
    VENUS SHELL™ is used for Accelerated Partial Breast Irradiation

Первичные конечные точки

  • Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site [Срок оценки: Treatment set-up (up to 21 days)]
  • Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm [Срок оценки: Study treatment (10 days)]
  • Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0 [Срок оценки: Through study completion (an average of 3 months)]
Вторичные конечные точки (3)
  • Patients' comfort (questionnaires) [Срок оценки: Treatment set-up (up to 21 days) and study treatment (10 days)]
  • Evaluate ease of use and overall satisfaction of using the VENUS SHELL (questionnaires) [Срок оценки: Study treatment (10 days)]
  • In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs) [Срок оценки: Radiotherapy treatment first session, up to last session (10 days)]

Критерии участия

Критерии включения

  • Written informed consent according to ICH/GCP regulations before registration and prior to any study-specific procedures
  • Upfront breast conservative surgery
  • Radiotherapy planned within 12 weeks after surgery
  • ECOG/WHO performance status ≤2
  • Age ≥40 year

For invasive breast cancer only:

  • Staging pT1-T2, N0M0 (Tumor size ≤3 cm)
  • If no sentinel lymph node biopsy performed, patient must be clinically N0
  • Negative margins (no tumor on ink)

For ductal carcinoma in situ only:

  • Staging pTis (tumor size ≤3 cm)
  • Negative margins (≥2 mm)

Критерии исключения

  • Patient of male sex
  • Inability to obtain informed consent or adhere to the CIP
  • Breast skin damage that could prevent VENUS SHELL™ usage according to protocol timeline (e.g. presence of any skin or soft tissue wound that failed to show evidence of progression towards healing, clinical signs of active infection at or immediately adjacent to the intended intervention site, etc.)
  • Known germline BRCA1/2 mutation
  • Unable to lay prone
  • Unable to undergo imaging by CT scan
  • Documented hypersensitivity or allergy to medical plasters, acrylonitrile butadiene styrene
  • Any serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may affect patient compliance or place the patient at high risk within the study.
  • Pregnancy or breast feeding
  • Claustrophobia
  • Patient with a body weight exceeding 120 kg
  • Patient with pendulous breasts that come into contact with the CT table, preventing adequate space for shell usage
  • Presence of any cardiac implantable electronic device (CIED), including but not limited to a pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or other electronically active implant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • NYU Grossman School of Medicine — New York

Идентификаторы

NCT: NCT07711847 · SHIELD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗