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

Not Applicable

Recruiting

• Conditions: Intestinal Neuroendocrine Tumor

• Registration Number: NCT06876532
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-14
• Status Verified: 2025-04
• Study Start: 2025-04-07
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-03
• Study Completion: 2031-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre François Baclesse; 🇫🇷 Caen, France

CHU de Lille; 🇫🇷 Lille, France

CHU de Lyon; 🇫🇷 Lyon, France

Hôpital La Timone; 🇫🇷 Marseille, France

CHU Hôtel Dieu; 🇫🇷 Nantes, France

CHU de Poitiers; 🇫🇷 Poitiers, France

IUCT-O; 🇫🇷 Toulouse, France