Intestinal Neuroendocrine Tumor
Conditions
Keywords
Intestinal Neuroendocrine Tumor, Lu-177 oxodotreotide, IBI score, Biomarker
Brief summary
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.
Interventions
OTHERAdditional 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.
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged ≥ 18 years. 2. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic. 3. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization. 4. 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%. 5. Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI. 6. Patient affiliated to a social security scheme in France. 7. Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.
Exclusion criteria
1. Previous treatment with Lu-177 oxodotreotide. 2. Any contraindication to treatment with Lu-177 oxodotreotide. 3. Morbid obesity (BMI \> 40). 4. Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion. 5. Active carcinoid heart disease or other acute cardiovascular event. 6. Active infection not treated within 15 days. 7. Pregnant or breast-feeding woman. 8. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol. 9. Patient deprived of liberty or under legal protection (guardianship, legal protection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients. | 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. | 12 months for each patient |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Imaging 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 |
Countries
France
Contacts
CONTACTLavinia VIJA
Outcome results
None listed