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
Recruiting now · Not applicable
Conditions studied: Intestinal Neuroendocrine Tumor
In brief
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.
Key facts
- Study ID
- NCT06876532
- Run by
- Institut Claudius Regaud
- People needed
- 150
- Starts
- 2025-04-07
- Expected to finish
- 2031-04-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Active carcinoid heart disease or other acute cardiovascular event.
- Active infection not treated within 15 days.
- Pregnant or breast-feeding woman.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
- Patient deprived of liberty or under legal protection (guardianship, legal protection).
Where it is running
- IUCT-O — Toulouse, France (enrolling)
- CHU de Bordeaux — Bordeaux, France (enrolling)
- Centre François Baclesse — Caen, France (enrolling)
- CHU de Lille — Lille, France (enrolling)
- CHU de Lyon — Lyon, France (enrolling)
- Hôpital La Timone — Marseille, France (enrolling)
- Institut de Cancérologie de Montpellier — Montpellier, France (enrolling)
- CHU Hôtel Dieu — Nantes, France (enrolling)
- CHU de Poitiers — Poitiers, France (enrolling)
- Institut de Cancérologie de l'Ouest — Angers, France
Full record on ClinicalTrials.gov
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