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Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases

Study acronym: LUTARTERIAL
StatusRecruiting
PhasePhase 2
Started2021-09-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 23, 2025 (before its estimated September 24, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-18
Study Status, Study Design, Arms and Interventions, Eligibility v2
Primary completion date2023-03-24→2025-09-24
Completion date2024-09-24→2027-03-24
Enrollment target20→23
Study arms2→1
Eligibility criteria-1 characters
[...] : hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 10075.000/mm3 Age ≥ 18 years, no superior limit Contraception req [...]
2021-11-18
Not Yet Recruiting→Recruiting Study Status, Study Description, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-03-01→2023-03-24
Completion date2024-09-01→2024-09-24
Start dateestimated 2021-09-01→confirmed 2021-09-24
Eligibility criteria+413 characters
[...] d 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 L [...] perior 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 ® in [...] or fistula, cirrhosis (Child Pugh B8 or C…) Serum albu [...]
Study description-30 characters
[...] y liver, bone marrow) and extra-hepatic lesions if present. WeThe investigators will also evaluate whether the intra-hepatic infusion of on [...] ® will be administered by intra-arterial hepatic injection. (Based on literature data, anAn average enhancement ratio of 3.75 is expected from intra-arterial injection compared to intravenous results; Kratochwil 2010). Those 10 patients will be evaluated for 177Lu-DOTA-peptide [...]
Study sitesdetails revised at 4 of 4 sites
2021-04-07
Original filing
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).
Trial Details
NCT Number NCT04837885
Lead Sponsor University Hospital, Bordeaux
Collaborators: Advanced Accelerator Applications
Conditions Neuroendocrine Tumor, Liver Metastases, Neuroendocrine Gastroenteropancreatic Tumour
Enrollment 23 participants
Start Date 2021-09-24
Primary Completion 2025-09-24 (estimated)
Study Completion 2027-03-24 (estimated)
Updated on ClinicalTrials.gov 2025-07-23