MedTrace Logo

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

NCT06016855 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-17

No results posted yet for this study

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

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

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

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Kamran Idrees, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2027-05-28
Completion
2028-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016855 on ClinicalTrials.gov