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Intra-arterial hepatic (IAH) infusion of radiolabelled somatostatin analogs in GEP-NET patients with dominant liver metastases
EU CTIS ID: 2024-514785-39-00
What this study is testing
68Ga-DOTA-peptides uptake (SUVmax) in up to 5 liver metastases on PET-scan obtained after intra-hepatic radiolabeled somatostatin analogs (SSA) infusion and on PET-scan obtained after intravenous radiolabeled SSA administration
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP)
- Patient´s signed written informed consent
- Patient affiliated to a social security system
- Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the 4 cycles
- 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
You likely can't join if
- 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)
- 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
- Or no residual uptake according to standard 177-Lu tomoscintigraphy performed in the clinical routine 24 hours after the last LUTATHERA IV treatment
- Carcinoid heart disease (LVEF < 40%)
See the full eligibility criteria
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP)
- Patient´s signed written informed consent
- Patient affiliated to a social security system
- Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the 4 cycles
- 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
- 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
- Highly effective contraception for women of childbearing potential (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomised partner, sexual abstinence, Implant). Contraception for men (condom) or their sexual partner (effective contraception) (CTFG recommandations : https://www.hma.eu/fileadmin/dateien/Human_Medicines/01- About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraceptio n_guidance_Version_1.1_updated.pdf). Contraception must be maintained for at least 7 months after the last LUTATHERA ® injection for women with childbearing capacity and at least 4 months for men who have female partners with childbearing capacity
- 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)
- 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
- Or no residual uptake according to standard 177-Lu tomoscintigraphy performed in the clinical routine 24 hours after the last 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.
- Pregnancy or breast feeding
- Currently participating to another category 1 or 2 clinical research protocol
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.