NCT06876532Recruiting
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 · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 7 Apr 2025
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT06876532
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 7 Apr 2025 to the primary completion date, 30 Apr 2029
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Morbid obesity (BMI \> 40).
- Pregnant or breast-feeding woman.
- Patient deprived of liberty or under legal protection (guardianship, legal protection).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Not yet recruiting |
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Lyon Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpital la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut de Cancérologie de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| IUCT-O Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.