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

NCT06876532 | Recruiting

• 1 other identifier: 24DIGE02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 10

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 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

Intestinal Neuroendocrine Tumor

Keywords

Intestinal Neuroendocrine Tumor; Lu-177 oxodotreotide; IBI score; Biomarker

Outcome Measures

Primary Outcomes (2)

• Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.

  12 months for each patient

• Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.

  12 months for each patient

Secondary Outcomes (5)

• The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.

  36 months for each patient

• The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.

  36 months for each patient

• Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.

  36 months for each patient

• Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.

  36 months for each patient

• Progression-free survival (PFS) rates (time from inclusion to progression or death from any cause) will be estimated with their 95% confidence intervals using the Kaplan-Meier method.

  36 months for each patient

Study Arms (1)

Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour

OTHER

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

Interventions

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

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.

Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous treatment with Lu-177 oxodotreotide.
• Any contraindication to treatment with Lu-177 oxodotreotide.
• Morbid obesity (BMI \> 40).
• 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).

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (10)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

NOT YET RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

CHU de Lille

Lille, France

RECRUITING

CHU de Lyon

Lyon, France

RECRUITING

Hôpital La Timone

Marseille, France

RECRUITING

Institut de Cancérologie de Montpellier

Montpellier, France

RECRUITING

CHU Hôtel Dieu

Nantes, France

RECRUITING

CHU de Poitiers

Poitiers, France

RECRUITING

IUCT-O

Toulouse, France

RECRUITING

MeSH Terms

Interventions

Serum Albumin; Data Collection

Intervention Hierarchy (Ancestors)

Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lavinia VIJA

CONTACT

05 31 15 56 47; Vija.Lavinia@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2031
• Last Updated: July 13, 2026

Record last verified: 2025-11

Locations

FR (10)