NCT03724409

Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases

Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sandeep Laroia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a safety study to determine the phase 1 starting dose of \[90\]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

Detailed description

\[90\]Yttrium-DOTATOC is a radioactive drug used for peptide receptor radionuclide therapy (PRRT). In other studies, 90Y-DOTATOC has been administered through a vein (IV) to target somatostatin receptor positive tumor tissue. The DOTATOC identifies the tumor through the somatostatin receptor and links to it, attaching the radioactive molecule 90Yttrium to the malignant cell. This study expands the initial work to examine if administering the drug 90Y-DOTATOC directly to the liver is safe for patients with neuroendocrine tumors whose disease has spread to their tumor. We don't know how of the 90Y-DOTATOC is safe to administer. We want to learn what the maximum safe dose is and what the side effects are related to that dose.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	[90]Y-DOTATOC	Intra-arterial infusion to the liver of \[90\]Y-DOTATOC. The administered dose is determined by cohort and is dependent upon the results of the previous cohort.

Timeline

• Start date: 2018-10-11
• Primary completion: 2021-03-21
• Completion: 2023-05-23
• First posted: 2018-10-30
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study