Evaluating a blood test to predict treatment response in patients with intestinal neuroendocrine tumors
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
This study is testing if a blood test can help predict how well a new treatment works for patients with advanced intestinal neuroendocrine tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT06876532 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, open-label study aims to assess the Inflammation Based Index (IBI) score as a predictive marker for clinical and radiological responses in patients with inoperable or metastatic, progressive grade 1 or 2 intestinal neuroendocrine tumors treated with Lu-177 oxodotreotide. The IBI score is calculated based on C-reactive protein and albumin levels, categorizing patients into low, intermediate, or high mortality risk. The study will involve additional blood tests and data collection to evaluate the effectiveness of the IBI score in predicting treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed grade 1 or 2 neuroendocrine tumors that are inoperable or metastatic.
Not a fit: Patients who have previously received Lu-177 oxodotreotide or have contraindications to this treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker to predict treatment responses, potentially improving patient management and outcomes.
How similar studies have performed: While the use of inflammatory markers as predictive tools is established in other contexts, this specific application of the IBI score in neuroendocrine tumors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Angers and 8 other locations
- Institut de Cancérologie de l'Ouest — Angers, France (Not_yet_recruiting)
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- Centre François Baclesse — Caen, France (Recruiting)
- CHU de Lille — Lille, France (Recruiting)
- CHU de Lyon — Lyon, France (Not_yet_recruiting)
- Hôpital La Timone — Marseille, France (Not_yet_recruiting)
- CHU Hôtel Dieu — Nantes, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Not_yet_recruiting)
- Iuct-O — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Lavinia VIJA
- Email: Vija.Lavinia@iuct-oncopole.fr
- Phone: 05 31 15 56 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.