NCT04609592

Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.

Detailed description

Primary Objective(s) * To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s) * To assess response rate (RR) after 2 cycles 177Lu Dotatate * To assess recurrence free survival (RFS) of the overall treatment strategy * To assess overall survival (OS) of the overall treatment strategy

Conditions

• Gastroenteropancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Lutathera	4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T
DRUG	Gallium 68 Dotatate	Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)
PROCEDURE	Computed Tomography (CT)	Medical Imaging
PROCEDURE	Magnetic Resonance Imaging (MRI)	Medical Imaging
PROCEDURE	PET/CT	Medical Imaging

Timeline

• Start date: 2021-03-17
• Primary completion: 2026-07-01
• Completion: 2027-09-01
• First posted: 2020-10-30
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study