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

Обзор

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.

Вмешательства

• Другое Additional blood tests (CRP and serum albumin) and data collection.
  These blood tests will be carried out on several occasions (before, during and after treatment with Lu-177 oxodotreotide). No additional blood sampling is required. In addition, patient clinical data and imaging data (standard examinations: thoraco-abdomino-pelvic CT +/- MRI and Ga-68 DOTA PET-CT) will be specifically collected for study purposes. For IUCT-O patients only: blood samples may be taken (at cycles 1 and 2, then 12 months after inclusion) for bio-banking purposes.

Первичные конечные точки

• Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients. [Срок оценки: 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. [Срок оценки: 12 months for each patient]

Вторичные конечные точки (5)

• The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint. [Срок оценки: 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. [Срок оценки: 36 months for each patient]
• Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics. [Срок оценки: 36 months for each patient]
• Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics. [Срок оценки: 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. [Срок оценки: 36 months for each patient]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 10 центров

• Institut de Cancérologie de l'Ouest — Angers
• CHU de Bordeaux — Bordeaux
• Centre François Baclesse — Caen
• CHU de Lille — Lille
• CHU de Lyon — Lyon
• Hôpital La Timone — Marseille
• Institut de Cancérologie de Montpellier — Montpellier
• CHU Hôtel Dieu — Nantes
• … и ещё 2 центра

Идентификаторы

NCT: NCT06876532 · 24DIGE02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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