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Идёт набор NCT07053982

Use of a New Diagnostic Tool in the Detection and Characterization of Endometriosis Lesions

Без фазы С лечением Endometriosis

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: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery.
Кому может быть актуально
Состояния в реестре: Endometriosis. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

18F]-FES PET in the Detection and Characterization of Endometriosis Lesions

Обзор

Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. \[18F\]-FES PET/CT could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of ER from diagnosis and thus helping to guide therapeutic care. We will thus attempt to correlate the intensity of \[18F\]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.

Подробное описание

Endometriosis is a chronic estrogen-dependent gynecological condition that leads to impaired overall quality of life due to infertility and associated pain. Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. There are several anatomo-clinical pathological entities. Thus, its painful symptoms vary greatly in its location and intensity. MRI, the reference examination for diagnosis but operator dependent, shows imperfect sensitivity. The diagnosis and characterization of lesions must therefore be improved. We know that 17β-estradiol, a key hormone for lesion growth, can also be produced locally by endometriotic tissue. The hypothesis according to which this local accumulation of estrogens plays an important role in the development of lesions by modulating the expression of RE must be studied. The use of new tools to study estrogen receptor expression should be evaluated at diagnosis. A new examination, \[18F\]-FES PET/CT, could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of the ER from the diagnosis and thus help to guide therapeutic care. \[18F\]-FES PET/CT is a non-invasive, operator-independent method that visualizes and quantifies ER expression in multiple tumors. Some studies have shown that \[18F\]-FES uptake correlates well with ER expression measured by immunohistochemistry staining. We will thus attempt to correlate the intensity of \[18F\]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.

Вмешательства

  • Процедура Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery
    This study includes preoperative \[18F\]-FES PET/CT imaging to assess estrogen receptor expression in endometriosis patients undergoing laparoscopic or robot-assisted surgery. Pain levels will be evaluated using VAS, BPI, HADS, and SF-36 scales. Immunohistochemistry and quantitative mRNA expression analysis (ESR1, ESR2, GPER) will be performed on excised lesions using Tissue Microarray. This approach aims to correlate PET/CT imaging findings with histological and molecular data, distinguishing i

Первичные конечные точки

  • Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT [Срок оценки: Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment.]
Вторичные конечные точки (5)
  • Characterization of Lesion Staining by Immunohistochemistry and In Situ Hybridization: Intensity and Receptor Expression by Anatomical Location. [Срок оценки: From tissue collection at surgery to completion of immunohistochemical and in situ hybridization analyses (approximately 4 weeks post-surgery).]
  • Sensitivity of [18F]-FES PET/CT Compared to MRI for Diagnosing Superficial and Deep Endometriotic Lesions by Anatomical Location. [Срок оценки: From completion of MRI and [18F]-FES PET/CT imaging (performed within 4 weeks prior to surgery) to histopathological analysis of lesions obtained during surgery (within 4 weeks post-imaging); total assessment period: up to 8 weeks per participant]
  • Association Between [18F]-FES SUV Intensity, Estrogen Receptor Expression (IHC), and Pain Severity (VAS Score) [Срок оценки: From the date of [18F]-FES PET/CT imaging (≤4 weeks before surgery) to the date of surgery and completion of pain assessments (VAS and BPI) and histopathological analysis of surgical samples; total duration of assessment per participant : up to 8 weeks]
  • Correlation Between Estrogen Receptor Expression in IHC/ISH and Pain Intensity (VAS) in Endometriosis [Срок оценки: From surgery (biopsy collection) to completion of pain assessment and histological analysis; up to 8 weeks.]
  • Correlation Between Estrogen Receptor mRNA Expression and Pain Intensity (VAS) in Endometriosis [Срок оценки: From surgery (biopsy collection) to completion of ISH and VAS assessments; up to 8 weeks.]

Критерии участия

Критерии включения

Cases:

\- Painful patients with a VAS ≥ 4 treated surgically for painful symptoms related to endometriosis;

Controls:

  • Patient with a VAS < 4 treated surgically for endometriosis in the context of infertility;
  • Age > 18 years;
  • Patient who provided informed consent;
  • Patients who underwent a preoperative MRI and were not contraindicated for \[18F\]-FES PET/CT;
  • Patient who underwent surgery mid-cycle;
  • Affiliation to a social security scheme

Критерии исключения

  • Patient treated for endometriosis without surgery;
  • Pregnant patient
  • Patient taking hormone therapy
  • Menopausal patient
  • Hypersensitivity to the active substance (Fluoroestradiol (18F)) or to any of the excipients
  • Patient under legal protection
  • Claustrophobic patient

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • Toulouse, Rangueil Hospital — Toulouse

Идентификаторы

NCT: NCT07053982 · RC31/23/0622 · 2025-520637-24-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗