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

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

Trial Details

NCT ID
NCT04837885
Phase
PHASE2
Sponsor
University Hospital, Bordeaux
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection
  • Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection
  • LUTATHERA® by intra-arterial hepatic (IAH) injection
  • Scan
Locations (sample)
  • Bordeaux, France|44.84124,-0.58046
  • Nîmes, France|43.83665,4.35788
  • Pessac, France|44.80565,-0.6324
  • Toulouse, France|43.60426,1.44367

Key Eligibility 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 …
  • 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

For full eligibility, visit ClinicalTrials.gov.

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