NCT06876532招募中不适用
Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
研究概览
简要总结
This is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the Inflammation Based Index (IBI) score as a marker for predicting clinical and radiological response in patients treated with Lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors.
This IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows:
- IBI = 0: Low mortality risk (if CRP and serum albumin values are considered normal in the investigator's judgment).
- IBI > 0, including: IBI = 1: Intermediate risk of mortality (if one of the two values is considered abnormal and clinically significant according to the investigator's judgment (either hypoalbuminemia or elevated CRP)); IBI = 2: High mortality risk (if both values are considered abnormal and clinically significant according to the investigator's judgment (hypoalbuminemia and elevated CRP)).
Patients were followed up for 36 months.
A total of 150 patients should be included in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient aged ≥ 18 years.
- •Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.
- •Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization.
- •Evidence of progression in the 12 months preceding Lu-177oxodotreotide therapy, confirmed by imaging techniques commonly used in current practice (thoraco-abdomino-pelvic CT and/or liver MRI, Ga-68 DOTA somatostatin analog PET-CT) +/- liver involvement greater than 50%.
- •Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI.
- •Patient affiliated to a social security scheme in France.
- •Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.
排除标准
- •Previous treatment with Lu-177 oxodotreotide.
- •Any contraindication to treatment with Lu-177 oxodotreotide.
- •Morbid obesity (BMI > 40).
- •Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.
- •Active carcinoid heart disease or other acute cardiovascular event.
- •Active infection not treated within 15 days.
- •Pregnant or breast-feeding woman.
- •Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
- •Patient deprived of liberty or under legal protection (guardianship, legal protection).
研究组 & 干预措施
Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
Other
干预措施: Additional blood tests (CRP and serum albumin) and data collection. (Other)
结局指标
主要结局
Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
时间窗: 12 months for each patient
Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.
时间窗: 12 months for each patient
次要结局
- Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.(36 months for each patient)
- The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.(36 months for each patient)
- The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.(36 months for each patient)
- Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.(36 months for each patient)
- Progression-free survival (PFS) rates (time from inclusion to progression or death from any cause) will be estimated with their 95% confidence intervals using the Kaplan-Meier method.(36 months for each patient)
研究者
研究点 (17)
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