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Идёт набор NCT06708910

AI-based pCR Assessment/Prediction in HER2-Positive BC Using PET/MRI

— Наблюдательное HER2 Positive Breast Carcinoma

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: HER2 Positive Breast Carcinoma. 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
Германия
Следующий шаг
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Официальное название

Multiparametric 18F-FDG PET/MRI for Assessment and Prediction of Locoregional Therapy Response in HER2-positive Breast Cancer Patients Using Artificial Intelligence

Обзор

Goal of the observational study: Based on PET/MRI data it is possible to differentiate between complete and incomplete pathological remission after neoadjuvant systemic therapy in HER2-positive breast cancer patients. The main question it aims to answer are: Primary endpoint: 1\) Sensitivity and specificity as co-primary endpoints for identification of HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment) Secondary endpoint(s): 1. Accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR; yT0 yN0) using 18F-FDG PET/MRI (response assessment) 2. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of the primary (yT0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment) 3. Sensitivity, specificity, and accuracy for the identification of patients with HER2-positive breast carcinoma with complete pathologic remission (pCR) of locoregional lymph node metastases (yN0) after neoadjuvant therapy using 18F-FDG PET/MRI (response assessment) 4. Evaluation of pre-treatment (baseline) 18F-FDG PET/MRI for predicting therapy response of the primary and locoregional lymph node metastases in patients with HER2-positive breast carcinoma supported by artificial-intelligence (prediction) 5. Evaluation of 18F-FDG PET/MRI for predicting therapy response of the primary in patients with HER2-positive breast carcinoma after the first cycles of systemic therapy supported by artificial-intelligence (prediction) 6. Evaluation of 18F-FDG PET/MRI for predicting therapy response of locoregional lymph node metastases in patients with HER2-positive breast carcinoma after the first cycles of system therapy supported by artificial-intelligence (prediction) The guideline-recommended staging procedure (S3 Germany) using CT will be replaced by a whole-body 18F-FDG PET/MRI, including dedicated 18F-FDG PET/MRI of the breast. The histopathologic results of tissue samples obtained during routine clinical treatment after successful neoadjuvant systemic therapy will serve as a reference standard. The study protocol involves the following examinations for all included patients: 1. Baseline (pre-treatment) examination to substitute for the staging examinations specified in the S3 guideline: Initial whole-body 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast 2. Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after the first two cycles of systemic therapy 3. Thoracic 18F-FDG PET/MRI including 18F-FDG PET/MRI of the breast after completion of systemic therapy and immediately before clinically indicated surgery

Первичные конечные точки

  • Response assessment Primary EP [Срок оценки: From enrollment to the end of treatment at 15 weeks]
Вторичные конечные точки (6)
  • Response assessment 1 [Срок оценки: From enrollment to the end of treatment at 15 weeks]
  • Response assessment 2 [Срок оценки: From enrollment to the end of treatment at 15 weeks]
  • Response assessment 3 [Срок оценки: From enrollment to the end of treatment at 15 weeks]
  • Prediction 1 [Срок оценки: post baseline staging]
  • Prediction 2 [Срок оценки: 3 weeks post NAST start]
  • Prediction 3 [Срок оценки: 3 weeks post NAST start]

Критерии участия

Критерии включения

  • Female
  • HER2-positive breast carcinoma
  • legally competent female patients aged ≥ 18 years
  • willing and able to attend scheduled examinations
  • written informed consent for study participation
  • decision to receive neoadjuvant systemic therapy / exclusion of distant metastases

Критерии исключения

  • previous cancer diagnosis within the last five years or second, synchronous malignancy
  • contraindication to MRI examination
  • severe renal insufficiency
  • pregnancy or lactation

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Department of Diagnostic and Interventional Radiology, Medical Faculty and University Hosp — Düsseldorf

Идентификаторы

NCT: NCT06708910 · 533909315 · KI 2434/4-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗