Intra-arterial liver infusion of radiolabeled somatostatin drugs for gastroenteropancreatic neuroendocrine tumors with dominant liver metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional project compares intra-hepatic arterial versus standard intravenous delivery of radiolabeled somatostatin analogs in patients with well-differentiated GEP-NETs and dominant liver metastases. Participants who have completed four standard intravenous Lutathera cycles undergo two 68Ga-DOTA-peptide PET scans—one after intra-hepatic injection and one after intravenous injection—to compare uptake in selected liver lesions and in dose-limiting organs. The protocol also includes a safety evaluation of a single intra-hepatic therapeutic Lutathera infusion following the four standard IV cycles. Imaging and dosimetry data will be used to quantify tumor targeting and organ exposure for the two delivery routes.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Bordeaux - Hôpital Haut Lévêque
  Pessac, France Recruiting
• Institut Bergonié
  Bordeaux, France Not yet recruiting
• Institut de cancérologie du Gard (ICG) - CHU de Nîmes
  Nîmes, France Not yet recruiting
• Institut universitaire du cancer de Toulouse (IUCT) Oncopole
  Toulouse, France Not yet recruiting

Study contacts

• Principal investigator: Ghoufrane TLILI — University Hospital, Bordeaux
• Study coordinator: Ghoufrane TLILI, Dr
• Email: ghoufrane.tlili@chu-bordeaux.fr
• Phone: 05 57 65 64 08

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.