Intestinal Neuroendocrine TumorLUTIBINCT06876532
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
A study testing Additional blood tests (CRP and serum albumin) and data collection. in people with Intestinal Neuroendocrine Tumor, run by Institut Claudius Regaud at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Neuroendocrine Tumor
- What is being tested?
- Additional blood tests (CRP and serum albumin) and data collection.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 10 sitesFrance
- Study dates
- 7 Apr 2025to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.
Who cannot join
- Previous treatment with Lu-177 oxodotreotide.
- Any contraindication to treatment with Lu-177 oxodotreotide.
- Morbid obesity (BMI > 40).
- Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.
- Active carcinoid heart disease or other acute cardiovascular event.
- Active infection not treated within 15 days.
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- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Angers, 49055
Marie LACOMBE, Dr, 02 41 35 27 00, Marie.lacombe@ico.unicancer.fr
- Recruiting
CHU de Bordeaux
Bordeaux
Magalie HAISSAGUERE, 05 57 65 65 27, Magalie.Haissaguerre@chu-bordeaux.fr
- Recruiting
Centre François Baclesse
Caen
Elisabeth QUAK, 02 31 45 50 32, E.Quak@baclesse.unicancer.fr
- Recruiting
CHU de Lille
Lille
Amandine BERON, 03 20 44 67 96, Amandine.Beron@chu-lille.fr
- Recruiting
CHU de Lyon
Lyon
Choaib LACHACHI, 04 72 35 73 34, Choaib.Lachachi@chu-lyon.fr
- Recruiting
Hôpital La Timone
Marseille
David TAÏEB, 04 91 38 59 04, David.Taieb@ap-hm.fr
- Recruiting
Institut de Cancérologie de Montpellier
Montpellier
Emmanuel DESHAYES, MD, +33467613190
- Recruiting
CHU Hôtel Dieu
Nantes
Catherine ANSQUER, 02 40 08 41 36, Catherine.Ansquer@chu-nantes.fr
- Recruiting
CHU de Poitiers
Poitiers
Claire LATAPPY, 05 49 44 44 58, Claire.Latappy@chu-poitiers.fr
- Recruiting
IUCT-O
Toulouse
Lavinia VIJA, 05 31 15 56 47, Vija.Lavinia@iuct-oncopole.fr
About this study
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:
Read more
- 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
- Being tested
- Additional blood tests (CRP and serum albumin) and data collection.
- Keywords
- Intestinal Neuroendocrine Tumor, Lu-177 oxodotreotide, IBI score, Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour | Other | Not described Receives: Other: Additional blood tests (CRP and serum albumin) and data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months for each patient
Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Measured: 36 months for each patient
Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Measured: 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.
Measured: 36 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start7 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Neuroendocrine TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876532
- Sponsor's protocol ID
- 24DIGE02
- Acronym
- LUTIBI
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06876532
- Acronym / sponsor ID
- LUTIBI / 24DIGE02
- Conditions
- Intestinal Neuroendocrine Tumor
- Keywords
- Intestinal Neuroendocrine Tumor, Lu-177 oxodotreotide, IBI score, Biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour | Other | Other: Additional blood tests (CRP and serum albumin) and data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Previous treatment with Lu-177 oxodotreotide.
- Any contraindication to treatment with Lu-177 oxodotreotide.
- Morbid obesity (BMI > 40).
- Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.
- Active carcinoid heart disease or other acute cardiovascular event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour |
Primary outcome
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
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
5 secondary outcomes
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
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
Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional blood tests (CRP and serum albumin) and data collection. in people with Intestinal Neuroendocrine Tumor, run by Institut Claudius Regaud at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lavinia VIJA (05 31 15 56 47, Vija.Lavinia@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.