Clinical trial NCT06876532: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intestinal Neuroendocrine Tumor
Keywords: Intestinal Neuroendocrine Tumor
Lu-177 oxodotreotide
IBI score
Biomarker
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
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:
measure: The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
timeFrame: 36 months for each patient
measure: The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
timeFrame: 36 months for each patient
measure: Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
timeFrame: 36 months for each patient
measure: Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
timeFrame: 36 months for each patient
measure: 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.
timeFrame: 36 months for each patient
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: Hôpital La Timone
city: Nantes
country: France
facility: CHU Hôtel Dieu
city: Poitiers
country: France
facility: CHU de Poitiers
city: Toulouse
country: France
facility: IUCT-O
Study officials:
References: