Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06876532
NA

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

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-04-07

Completion Date

2031-04

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

OTHER

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

These blood tests will be carried out on several occasions (before, during and after treatment with Lu-177 oxodotreotide). No additional blood sampling is required. In addition, patient clinical data and imaging data (standard examinations: thoraco-abdomino-pelvic CT +/- MRI and Ga-68 DOTA PET-CT) will be specifically collected for study purposes. For IUCT-O patients only: blood samples may be taken (at cycles 1 and 2, then 12 months after inclusion) for bio-banking purposes.

Locations (9)

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

CHU Hôtel Dieu

Nantes, France

CHU de Poitiers

Poitiers, France

IUCT-O

Toulouse, France