Actively 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
Led by Institut Claudius Regaud · Updated on 2025-11-18
150
Participants Needed
9
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 65 18 years.
- Histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.
- Eligible for Lu-177 oxodotreotide therapy according to its marketing authorization.
- Evidence of disease progression in the 12 months before Lu-177 oxodotreotide therapy confirmed by imaging.
- Disease measurable by RECIST 1.1 criteria on thoraco-abdomino-pelvic CT and/or liver MRI.
- Affiliated to a social security scheme in France.
- Signed informed consent before study inclusion and procedures.
You will not qualify if you...
- Previous treatment with Lu-177 oxodotreotide.
- Contraindications to Lu-177 oxodotreotide treatment.
- Morbid obesity (BMI > 40).
- Uncontrolled or unbalanced active inflammatory disease within 3 months before inclusion.
- Active carcinoid heart disease or recent acute cardiovascular event.
- Active infection untreated within 15 days.
- Pregnancy or breastfeeding.
- Psychological, family, geographical, or sociological issues preventing compliance with study follow-up or procedures.
- Being deprived of liberty or under legal protection (guardianship or legal protection).
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Trial Site Locations
Total: 9 locations
1
Institut de Cancérologie de l'Ouest
Angers, France, 49055
Not Yet Recruiting
2
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
3
Centre François Baclesse
Caen, France
Actively Recruiting
4
CHU de Lille
Lille, France
Actively Recruiting
5
CHU de Lyon
Lyon, France
Not Yet Recruiting
6
Hôpital La Timone
Marseille, France
Not Yet Recruiting
7
CHU Hôtel Dieu
Nantes, France
Actively Recruiting
8
CHU de Poitiers
Poitiers, France
Not Yet Recruiting
9
IUCT-O
Toulouse, France
Actively Recruiting
Research Team
L
Lavinia VIJA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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