Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06016855

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

Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-12-17

6

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated written informed consent
  • Male or female 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor grade 1 or 2 (Ki-67 ≤ 20%)
  • Somatostatin receptor avidity on baseline copper-64 dotatate PET/CT scan within 6 months prior to surgery, with uptake in majority of lesions at or above normal liver uptake
  • Presence of hepatic metastasis (may have other metastatic sites)
  • White blood cell count ≥ 2000/uL within 90 days before surgery
  • Platelet count ≥ 75,000/uL within 90 days before surgery
  • Hemoglobin ≥ 8.0 g/dL within 90 days before surgery
  • Creatinine clearance ≥ 30 mL/min within 90 days before surgery
  • Total bilirubin ≤ 3.0 times institutional upper limit of normal within 90 days before surgery
  • Serum albumin ≥ 3.0 g/dL within 90 days before surgery unless prothrombin time is normal
  • Women must not be breastfeeding and agree to avoid breastfeeding during treatment and for 2.5 months after last dose
  • Women of childbearing potential must have negative pregnancy test within 28 days before first dose and agree to use contraception until 7 months after last dose
  • Men able to father children must agree to use contraception until 4 months after last dose
Not Eligible

You will not qualify if you...

  • Presence of any tumor larger than 3 cm deemed inoperable
  • Disease considered completely surgically resectable
  • Grade 3 neuroendocrine neoplasm (well-differentiated or poorly differentiated)
  • Prior receipt of peptide receptor radionuclide therapy (PRRT)
  • Untreated or growing brain metastases within 90 days before surgery
  • Unstable angina, severe congestive heart failure (NYHA class III or IV), or uncontrolled symptomatic cardiac arrhythmia
  • Any other uncontrolled significant medical, psychiatric, or surgical condition that may interfere with study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

Loading map...

Research Team

V

Vanderbilt-Ingram Services for Timely Access

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here