NCT06833229招募中不适用
Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
研究概览
简要总结
The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years,
- •Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,
- •ECOG 0 to 3,
- •The patient's understanding of the protocol and the note of non-opposition, with oral agreement,
- •Patient has not objected to the use of his or her data for medical research. research,
- •Patient has social security coverage.
排除标准
- •Age under 18,
- •Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),
- •Hemoglobin less than 7 g/dL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g/dL,
- •Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,
- •Refusal to participate in the present study,
- •Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).
- •Vulnerable persons are defined in article L1121-5 to -8:
- •Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,
- •and persons admitted to a health or social establishment for purposes other than research purposes,
- •adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition
结局指标
主要结局
Metabolic criteria for PET imaging that can distinguish true tumor progression from pseudo-progression of inflammatory origin (leukocyte infiltrate)
时间窗: 36 months
Calculation of the area of the ROC curve and determination of the optimal threshold of different metabolic parameters extracted from the standard PET image (ΔSUVmax, ΔTLG, appearance of new visceral lesion(s)) and parametric PET image (metabolic glucose rate (Ki), volume of distribution (VD)) to distinguish lesions between true progression from inflammatory pseudoprogressions.
次要结局
- Incidence of pseudo-progressions versus true tumor progressions at the first PET scan at 6 weeks.(6 weeks)
- Prognostic value of metabolic response PET-CT at 6 weeks and 12 weeks on overall survival at 12, 24 and 36 months(36 months)
- Use of supervised deep-learning algorithms (neural networks) to classify patients as immunotherapy responders or non-responders.(6 months)
- Evaluation of overall survival of patients with oligometastatic progression with maintenance of immunotherapy and targeted irradiation of progressing lesions.(36 months)
研究者
研究点 (2)
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