Blood Inflammation Score Predicting Response to Lu-177 Oxodotreotide in Intestinal Neuroendocrine Tumour
Tests a blood inflammation score in people receiving Lu-177 oxodotreotide.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Angers, Bordeaux, Caen, Lille, Lyon, Marseille, Montpellier, Nantes, Poitiers, and Toulouse, FranceSee the 10 sites
Where in France
- Institut de Cancerologie de L'OuestAngers, FranceNot yet recruiting
- CHU de BordeauxBordeaux, FranceTaking people
- Centre François BaclesseCaen, FranceTaking people
- CHU de LilleLille, FranceTaking people
- CHU de LyonLyon, FranceTaking people
- Hôpital la TimoneMarseille, FranceTaking people
- Institut de Cancérologie de MontpellierMontpellier, FranceTaking people
- CHU Hôtel DieuNantes, FranceTaking people
- CHU de PoitiersPoitiers, FranceTaking people
- IUCT-OToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut Claudius Regaud
- Trial code
- NCT06876532
- Record updated
- 13 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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%; Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI; Patient affiliated to a social security scheme in France; Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.
Exclusion: Previous treatment with Lu-177 oxodotreotide; Any contraindication to treatment with Lu-177 oxodotreotide; Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion; Active carcinoid heart disease or other acute cardiovascular event; Active infection not treated within 15 days; Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol; Morbid obesity (BMI > 40); Pregnant or breast-feeding woman; Patient deprived of liberty or under legal protection (guardianship, legal protection).