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Recruiting 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

Conditions: Intestinal Neuroendocrine Tumor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Institut Claudius Regaud

Location: Institut de Cancérologie de l'Ouest Angers

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06876532). StuddyBuddy aggregates publicly available trial information.