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

NCT04609592 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: IRB-52341NET0030NCI-2021-03448
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• Measure Complication free Surgery

  The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows. * Radiation fibrosis * Hepatic fibrosis by histologic diagnosis * Hepatic insufficiency * Bowel anastamotic leak (if bowel surgery) * Distal pancreatic leak (if pancreas surgery)

  6 months

Secondary Outcomes (3)

• Response Rate (RR)

  16 weeks

• Recurrence free Survival (RFS)

  1 year

• Overall Survival (OS)

  1 year

Study Arms (1)

Lutathera

EXPERIMENTAL

2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT

Drug: Lutathera; Drug: Gallium 68 Dotatate; Procedure: Computed Tomography (CT); Procedure: Magnetic Resonance Imaging (MRI); Procedure: PET/CT

Interventions

Lutathera DRUG

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

Also known as: lutetium Lu 177 dotatate, (Lu 177)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10- tetraazacyclododec-1-yl) acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic (2-7) disulfide., 177 Lu-DOTA-octreotate

Lutathera

Gallium 68 Dotatate DRUG

Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)

Also known as: Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Lutathera

Computed Tomography (CT) PROCEDURE

Medical Imaging

Also known as: CT Scan

Lutathera

Magnetic Resonance Imaging (MRI) PROCEDURE

Medical Imaging

Lutathera

PET/CT PROCEDURE

Medical Imaging

Also known as: Positron Emission Tomography (PET)

Lutathera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.
• WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)
• Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion
• Measurable disease as determined by RECIST v1.1
• Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan
• Patients ≥ 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
• Appropriate hematologic, liver and kidney function
• Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study

You may not qualify if:

• Prior 177Lu Dotatate treatment
• Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \> 25% of bone marrow, at any time
• Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study
• Known brain metastases
• Known bone or peritoneal metastases

Sponsors & Collaborators

• Stanford University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Stanford Cancer Institute Palo Alto

Stanford, California, 95304, United States

RECRUITING

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Interventions

lutetium Lu 177 dotatate; Disulfides; gallium Ga 68 dotatate; Ga(III)-DOTATOC; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Brendan C Visser, MD

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

CONTACT

(650) 498-7757; gpineda@stanford.edu

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

CONTACT

(650) 498-7757; gitrialeligibility@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: March 17, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)