About this trial
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.
Eligibility criteria
Qualifiers
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%.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Additional blood tests (CRP and serum albumin) and data collection.