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 (LUTIBI)

November 14, 2025 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
Time Frame: 12 months for each patient
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.
Time Frame: 12 months for each patient
12 months for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.
Time Frame: 36 months for each patient
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.
Time Frame: 36 months for each patient
36 months for each patient
Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time Frame: 36 months for each patient
36 months for each patient
Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time Frame: 36 months for each patient
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.
Time Frame: 36 months for each patient
36 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24DIGE02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intestinal Neuroendocrine Tumor

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe