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

Last updated: April 9, 2025
Sponsor: Institut Claudius Regaud
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Digestive System Neoplasms

Abdominal Cancer

Treatment

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

Clinical Study ID

NCT06876532
24DIGE02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient aged ≥ 18 years.

  2. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of themidgut, inoperable or metastatic.

  3. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketingauthorization.

  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 anyspecific study procedure.

Exclusion

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 toinclusion.

  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 preventscompliance with the medical follow-up and/or procedures stipulated in the studyprotocol.

  9. Patient deprived of liberty or under legal protection (guardianship, legalprotection).

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Additional blood tests (CRP and serum albumin) and data collection.
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
March 31, 2031

Connect with a study center

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • Centre François Baclesse

    Caen,
    France

    Site Not Available

  • CHU de Lille

    Lille,
    France

    Site Not Available

  • CHU de Lyon

    Lyon,
    France

    Site Not Available

  • Hôpital La Timone

    Marseille,
    France

    Site Not Available

  • CHU Hôtel Dieu

    Nantes,
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers,
    France

    Site Not Available

  • IUCT-O

    Toulouse,
    France

    Active - Recruiting

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