An interventional study of Additional blood tests (CRP and serum albumin) and data collection. in Intestinal Neuroendocrine Tumor, sponsored by Institut Claudius Regaud. Recruiting at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other
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:
Patients were followed up for 36 months.
A total of 150 patients should be included in this study.
Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: 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.
Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
Time frame: 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.
Time frame: 12 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.
Time frame: 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.
Time frame: 36 months for each patient
Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time frame: 36 months for each patient
Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time frame: 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.
Time frame: 36 months for each patient
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Institut Claudius Regaud