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Идёт набор NCT06916637

Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer

— Наблюдательное Breast Cancer Breast Cancer, HER2-Expression

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: 18F-HER2 Affibody PET scan.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Breast Cancer, HER2-Expression. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

This study aims to evaluate the clinical utility of 18F-labeled HER2 Affibody PET for diagnosing and monitoring HER2-expressing breast cancer. HER2, a protein overexpressed in certain malignancies including breast cancer, serves as a critical biomarker for targeted therapies.The HER2 Affibody-an engineered 7 kDa protein with nanomolar affinity for HER2-leverages its rapid tumor penetration and clearance kinetics to achieve high-contrast PET imaging. This study aims to evaluate the diagnostic efficacy of 18F-HER2 Affibody PET in early detection, clinical staging, and treatment response monitoring, thereby providing novel imaging evidence to guide personalized therapeutic strategies for patients with HER2-expressing breast cancer.

Подробное описание

Human epidermal growth factor receptor 2 (HER2) is a transmembrane receptor protein with tyrosine kinase activity that plays a crucial role in cell growth, activation, and proliferation. While minimally expressed in normal tissues, HER2 is highly expressed in various malignant tumors, especially breast cancer, making it a key target for breast cancer diagnosis and treatment.HER2-positivity was defined with Immunohistochemistry (IHC) 3+ or IHC 2+ followed by Fluorescence In Situ Hybridization（FISH） showing HER2 amplification.HER2-low was defined IHC 1+ or IHC 2+ with negative FISH . Conventional diagnostic approaches like biopsy are inherently invasive and lack the capability for longitudinal evaluation of HER2 expression dynamics.The HER2-targeted Affibody molecule demonstrates superior diagnostic potential compared to traditional antibodies, attributed to its enhanced specificity, compact molecular structure enabling rapid biodistribution (achieving optimal blood clearance within 1-4 hours post-injection), and consequent high-contrast imaging capabilities. As a novel positron emission tomography (PET) tracer, 18F-HER2 Affibody holds promise for delivering precise, non-invasive quantification of HER2 status. This study seeks to systematically assess the diagnostic accuracy of 18F-HER2 Affibody PET in tumor staging and treatment stratification, while concurrently investigating its prognostic value through longitudinal treatment response monitoring in breast cancer patients with HER2-overexpressing tumors.

Вмешательства

  • Лучевая терапия 18F-HER2 Affibody PET scan
    HER2 Affibody, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-HER2 Affibody PET scan.

Первичные конечные точки

  • SUV [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Age 18-75 years, ECOG score 0 or 1.
  • Clinically or pathologically confirmed diagnosis of patients with HER2 expression breast cancer or suspected expression breast cancer.
  • Life expectancy ≥ 12 weeks.
  • At least one measurable target lesion according to RECIST 1.1 criteria.
  • All participants of reproductive potential (regardless of gender) must commit to using effective contraceptive methods throughout the trial participation and for 6 months after the last PET scan.
  • Ability to understand and voluntarily sign the informed consent form, with good compliance.

Критерии исключения

  • Severe hepatic or renal dysfunction.
  • Pregnant or lactating women, or women planning to become pregnant.
  • Inability to lie supine for half an hour.
  • Refusal to participate in this clinical study.
  • Suffering from claustrophobia or other mental illnesses.
  • Other conditions that the investigator deems unsuitable for participation in the trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Affiliated Hospital of Qingdao University — Qingdao

Идентификаторы

NCT: NCT06916637 · QDFY-NM-25006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗