Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-30 @ 7:15 AM
Study NCT ID:
NCT06876532
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.', 'timeFrame': '12 months for each patient'}, {'measure': 'Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.', 'timeFrame': '12 months for each patient'}], 'secondaryOutcomes': [{'measure': 'The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.', 'timeFrame': '36 months for each patient'}, {'measure': 'The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint.', 'timeFrame': '36 months for each patient'}, {'measure': 'Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.', 'timeFrame': '36 months for each patient'}, {'measure': 'Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics.', 'timeFrame': '36 months for each patient'}, {'measure': '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.', 'timeFrame': '36 months for each patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intestinal Neuroendocrine Tumor', 'Lu-177 oxodotreotide', 'IBI score', 'Biomarker'], 'conditions': ['Intestinal Neuroendocrine Tumor']}, 'descriptionModule': {'briefSummary': "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.\n\nThis IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows:\n\n* IBI = 0: Low mortality risk (if CRP and serum albumin values are considered normal in the investigator's judgment).\n* 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)).\n\nPatients were followed up for 36 months.\n\nA total of 150 patients should be included in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient aged ≥ 18 years.\n2. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.\n3. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization.\n4. 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%.\n5. Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI.\n6. Patient affiliated to a social security scheme in France.\n7. Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.\n\nExclusion Criteria:\n\n1. Previous treatment with Lu-177 oxodotreotide.\n2. Any contraindication to treatment with Lu-177 oxodotreotide.\n3. Morbid obesity (BMI \\> 40).\n4. Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.\n5. Active carcinoid heart disease or other acute cardiovascular event.\n6. Active infection not treated within 15 days.\n7. Pregnant or breast-feeding woman.\n8. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.\n9. Patient deprived of liberty or under legal protection (guardianship, legal protection).'}, 'identificationModule': {'nctId': 'NCT06876532', 'acronym': 'LUTIBI', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '24DIGE02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour', 'interventionNames': ['Other: Additional blood tests (CRP and serum albumin) and data collection.']}], 'interventions': [{'name': 'Additional blood tests (CRP and serum albumin) and data collection.', 'type': 'OTHER', 'description': '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.\n\nIn 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.\n\nFor IUCT-O patients only: blood samples may be taken (at cycles 1 and 2, then 12 months after inclusion) for bio-banking purposes.', 'armGroupLabels': ['Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie LACOMBE, Dr', 'role': 'CONTACT', 'email': 'Marie.lacombe@ico.unicancer.fr', 'phone': '02 41 35 27 00'}], 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Magalie HAISSAGUERE', 'role': 'CONTACT', 'email': 'Magalie.Haissaguerre@chu-bordeaux.fr', 'phone': '05 57 65 65 27'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisabeth QUAK', 'role': 'CONTACT', 'email': 'E.Quak@baclesse.unicancer.fr', 'phone': '02 31 45 50 32'}], 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amandine BERON', 'role': 'CONTACT', 'email': 'Amandine.Beron@chu-lille.fr', 'phone': '03 20 44 67 96'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Choaib LACHACHI', 'role': 'CONTACT', 'email': 'Choaib.Lachachi@chu-lyon.fr', 'phone': '04 72 35 73 34'}], 'facility': 'CHU de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'David TAÏEB', 'role': 'CONTACT', 'email': 'David.Taieb@ap-hm.fr', 'phone': '04 91 38 59 04'}], 'facility': 'Hôpital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine ANSQUER', 'role': 'CONTACT', 'email': 'Catherine.Ansquer@chu-nantes.fr', 'phone': '02 40 08 41 36'}], 'facility': 'CHU Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Poitiers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire LATAPPY', 'role': 'CONTACT', 'email': 'Claire.Latappy@chu-poitiers.fr', 'phone': '05 49 44 44 58'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lavinia VIJA', 'role': 'CONTACT', 'email': 'Vija.Lavinia@iuct-oncopole.fr', 'phone': '05 31 15 56 47'}], 'facility': 'IUCT-O', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Lavinia VIJA', 'role': 'CONTACT', 'email': 'Vija.Lavinia@iuct-oncopole.fr', 'phone': '05 31 15 56 47'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}