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

Launched by INSTITUT CLAUDIUS REGAUD · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well the Inflammation-Based Index (IBI) can predict how patients with advanced intestinal neuroendocrine tumors respond to a treatment called Lu-177 oxodotreotide. The IBI is determined by measuring two blood markers: C-reactive protein (CRP) and albumin. Depending on the levels of these markers, patients will be classified into different risk categories, which may help doctors understand how well the treatment is working. The trial will follow 150 patients over three years to gather important information about their health responses.

To be eligible for this study, patients need to be at least 18 years old and have a confirmed diagnosis of grade 1 or 2 intestinal neuroendocrine tumors that cannot be surgically removed or have spread to other areas. They should also have shown signs of disease progression in the past year and be approved for Lu-177 oxodotreotide treatment. Participants can expect regular follow-ups and assessments during the study, and they'll need to provide consent before joining. This trial is important because it could help improve how doctors predict treatment outcomes for patients facing this challenging condition.

Gender

ALL

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).