NCT06016855

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs

Detailed description

PRIMARY OBJECTIVES: I. To measure objective response rate of a combination standard of care treatment in gastroenteropancreatic neuroendocrine tumors by initiating lutetium Lu 177 dotatate within 90 days of surgical debulking. II. To assess the radiomic profile including somatostatin receptor standardized uptake values (SSTR SUV) of large and non-large tumors in study patients) III: To assess the safety and tolerability of peptide receptor radionuclide therapy (PRRT) post-surgical debulking in patients on study. IV. To assess the tumor genomic profile of large, resected tumors from patients and assess for signatures of radioresistance. OUTLINE: Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate (177Lu dotatate) intravenously (IV) over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the trial, and undergo copper Cu 64 dotatate positron emission tomography/CT (dotatate PET/CT) during screening and on study. After completion of study treatment, patients are followed up at 30-37 days after last dose and then every 3 months for 2 years.

Conditions

• Digestive System Neuroendocrine Tumor G1
• Digestive System Neuroendocrine Tumor G2
• Metastatic Digestive System Neuroendocrine Neoplasm
• Metastatic Malignant Neoplasm in the Liver
• Pancreatic Neuroendocrine Tumor G1
• Pancreatic Neuroendocrine Tumor G2

Interventions

Type	Name	Description
PROCEDURE	Tumor Debulking	Undergo surgical debulking
DRUG	Lutetium Lu 177 Dotatate	Given by IV
PROCEDURE	Computed Tomography	Undergo Computed Tomography
PROCEDURE	Magnetic Resonance Imaging	Undergo Magnetic Resonance Imaging
DRUG	Copper Cu 64 Dotatate	Given by IV
PROCEDURE	Positron Emission Tomography	Undergo Positron Emission Tomography

Timeline

• Start date: 2024-05-31
• Primary completion: 2027-05-28
• Completion: 2028-05-28
• First posted: 2023-08-30
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study