RecruitingPhase 1NCT04609592

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


Sponsor

Stanford University

Enrollment

10 participants

Start Date

Mar 17, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive treatment called PRRT (peptide receptor radionuclide therapy), which targets specific receptors on tumor cells, before surgery in people with metastatic neuroendocrine tumors (NETs) of the digestive system or pancreas. Researchers want to see if PRRT before surgery leads to better outcomes. **You may be eligible if...** - You have metastatic neuroendocrine tumors in the gut or pancreas (gastroenteropancreatic NET) with spread to lymph nodes or liver only - Your tumor is low to intermediate grade (WHO Grade 1 or 2, Ki-67 ≤ 20%) - A tumor board has determined your cancer can be surgically removed - Your tumors show up on a specific type of scan (68Ga DOTA TATE PET) - You are 18 or older and in reasonably good health **You may NOT be eligible if...** - Your cancer has spread beyond lymph nodes and liver - You have significant kidney, liver, or blood count problems - You are pregnant or breastfeeding - You have had prior PRRT treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutathera

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

DRUGGallium 68 Dotatate

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

PROCEDUREComputed Tomography (CT)

Medical Imaging

PROCEDUREMagnetic Resonance Imaging (MRI)

Medical Imaging

PROCEDUREPET/CT

Medical Imaging


Locations(1)

Stanford Cancer Institute Palo Alto

Stanford, California, United States

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NCT04609592


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