18F]-FES PET in the Detection and Characterization of Endometriosis Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Painful patients with a VAS ≥ 4 treated surgically for painful symptoms related to endometriosis;
- •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
排除标准
- •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
研究组 & 干预措施
Endometriosis Patients Undergoing Surgery for Severe Pain Management (EVA ≥ 4)
干预措施: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery (Procedure)
Endometriosis Patients Undergoing Surgery for Infertility Without Severe Pain (EVA < 4)
干预措施: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery (Procedure)
结局指标
主要结局
Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT
时间窗: Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment.
Estrogen receptor (ER) overexpression in endometriotic lesions will be assessed using the Standardized Uptake Value (SUV) on preoperative \[18F\]-FES PET/CT imaging. Each lesion's SUV will be quantified and compared within patients and between groups with high pain levels (VAS ≥ 4) and low or no pain (VAS \< 4). ER overexpression is defined as increased \[18F\]-FES uptake compared to background levels. The correlation between SUV values and pain severity will be analyzed to determine whether ER overexpression is associated with symptomatic burden. Higher SUV values indicate greater ER expression.
次要结局
- Correlation Between Estrogen Receptor mRNA Expression and Pain Intensity (VAS) in Endometriosis(From surgery (biopsy collection) to completion of ISH and VAS assessments; up to 8 weeks.)
- Characterization of Lesion Staining by Immunohistochemistry and In Situ Hybridization: Intensity and Receptor Expression by Anatomical Location.(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.(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)(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(From surgery (biopsy collection) to completion of pain assessment and histological analysis; up to 8 weeks.)