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.
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%.
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.
Single group
Additional blood tests (CRP and serum albumin) and data collection.
Other interventionThese 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.
Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.
The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
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