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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

RecruitingNAAges 18 Years - anyAllInstitut Claudius Regaud
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Additional blood tests (CRP and serum albumin) and data collection.
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Where

10 sites
Institut de Cancérologie de l'Ouest
Angers, France
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
Institut de Cancérologie de Montpellier
Montpellier, France
CHU Hôtel Dieu
Nantes, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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