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RECRUITING
NCT06016855
PHASE4

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

Sponsor: Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-05-31

Completion Date

2028-05-28

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States