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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

Study acronym: LUTIBI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 9 to 10v9
  2. Minor Site details revised at 1 of 9 sitesv8
  3. Minor Study sites: 8 to 9v7
  4. Minor Site details revised at 1 of 8 sitesv6
  5. Minor Primary completion date: Mar 2029 to Apr 2029
    • Study completion date: Mar 2031 to Apr 2031
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Start date changed from estimate of Apr 2025 to Apr 7, 2025v4
  2. Minor Start date: Mar 2025 to Apr 2025v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 8 of 8 sites
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06876532
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)
Intestinal Neuroendocrine Tumor
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov