NCT04837885 Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
| NCT ID | NCT04837885 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Bordeaux |
| Condition | Neuroendocrine Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2021-09-24 |
| Primary Completion | 2025-09-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 23 participants in total. It began in 2021-09-24 with a primary completion date of 2025-09-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Ghoufrane TLILI
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT04837885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04837885 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04837885 currently recruiting?
Yes, NCT04837885 is actively recruiting participants. Contact the research team at ghoufrane.tlili@chu-bordeaux.fr for enrollment information.
Where is the NCT04837885 trial being conducted?
This trial is being conducted at Bordeaux, France, Nîmes, France, Pessac, France, Toulouse, France.
Who is sponsoring the NCT04837885 clinical trial?
NCT04837885 is sponsored by University Hospital, Bordeaux. The principal investigator is Ghoufrane TLILI at University Hospital, Bordeaux. The trial plans to enroll 23 participants.