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

Overview

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.

Interventions

• Other Additional blood tests (CRP and serum albumin) and data collection.
  These blood tests will be carried out on several occasions (before, during and after treatment with Lu-177 oxodotreotide). No additional blood sampling is required. In addition, patient clinical data and imaging data (standard examinations: thoraco-abdomino-pelvic CT +/- MRI and Ga-68 DOTA PET-CT) will be specifically collected for study purposes. For IUCT-O patients only: blood samples may be taken (at cycles 1 and 2, then 12 months after inclusion) for bio-banking purposes.

Primary outcome measures

• Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients. [Time frame: 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. [Time frame: 12 months for each patient]

Secondary outcome measures (5)

• The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint. [Time frame: 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. [Time frame: 36 months for each patient]
• Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics. [Time frame: 36 months for each patient]
• Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics. [Time frame: 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. [Time frame: 36 months for each patient]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 10 centers

• Institut de Cancérologie de l'Ouest — Angers
• CHU de Bordeaux — Bordeaux
• Centre François Baclesse — Caen
• CHU de Lille — Lille
• CHU de Lyon — Lyon
• Hôpital La Timone — Marseille
• Institut de Cancérologie de Montpellier — Montpellier
• CHU Hôtel Dieu — Nantes
• … and 2 more centers

Identifiers

NCT: NCT06876532 · 24DIGE02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗