Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intestinal Neuroendocrine Tumor | Intestinal Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional blood tests (CRP and serum albumin) and data collection. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
- interventionNames
- Other: Additional blood tests (CRP and serum albumin) and data collection.
Primary outcomes (2)
- measure
- Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
- timeFrame
- 12 months for each patient
- measure
- Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.
- timeFrame
- 12 months for each patient
Secondary outcomes (5)
- measure
- The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
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