Clinical trial · Interventional
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
"Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"
NCT04837885CI-TRIAL-00092469LUTARTERIALrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
| Neuroendocrine Gastroenteropancreatic Tumour | — | UNRESOLVED | — |
| Neuroendocrine Tumor | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LUTATHERA® by intra-arterial hepatic (IAH) injection | Drug | — | UNRESOLVED |
| Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection | Procedure | — | UNRESOLVED |
| Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection | Procedure | — | UNRESOLVED |
| Scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTA-peptides PET/CT
- description
- 68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) One treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations
- interventionNames
- Procedure: Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection
- Procedure: Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection
- Drug: LUTATHERA® by intra-arterial hepatic (IAH) injection
- Procedure: Scan
Primary outcomes (2)
- measure
- Standardized uptake value (SUVmax) on liver metastases
- timeFrame
- Day 0 (First PET/CT)
- description
- Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP). * Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion \> 50% without waiting for tumour progression * Patient has received 4 standard of care LUTATHERA® cycles * Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle * ECOG performance status 0-2 * Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min, ALT/AST ≤ 2,5x the upper limit of normal * With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 75.000/mm3 * Age ≥ 18 years, no superior limit * Contraception required in pre-menopausal female (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomy, Implants) and men for at least 6 months after the last LUTATHERA ® injection. * Patient´s signed written informed consent * Patient affiliated to a social security system Exclusion Criteria: * Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI) * No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment * Carcinoid heart disease (LVEF \< 40%) * Dominant or threatening extrahepatic metastases or that may affect vital prognosis * Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…) * Serum albumin \<30 g/L unless prothrombin time is within the normal range. * Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months. * Individuals under legal protection or unable of giving their informed consent * Pregnancy or breast feeding * Currently participating to another clinical research protocol * Individuals under legal protection or unable of giving their informed consent * MRI scan contraindicated * LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose
References
Publications (0)
Data not yet available
No reference posted for this study.