Status:
RECRUITING
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
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Intestinal Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
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 radiologic...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06876532
Start Date
April 7 2025
End Date
April 1 2031
Last Update
November 18 2025
Active Locations (9)
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1
Institut de Cancérologie de l'Ouest
Angers, France, 49055
2
CHU de Bordeaux
Bordeaux, France
3
Centre François Baclesse
Caen, France
4
CHU de Lille
Lille, France