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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT06016855
Phase
PHASE4
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tumor Debulking — PROCEDURE
    Undergo surgical debulking
  • Lutetium Lu 177 Dotatate — DRUG
    Given by IV
  • Computed Tomography — PROCEDURE
    Undergo Computed Tomography
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo Magnetic Resonance Imaging
  • Copper Cu 64 Dotatate — DRUG
    Given by IV
  • Positron Emission Tomography — PROCEDURE
    Undergo Positron Emission Tomography

Study Details

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

Key Dates

Start date
May 31, 2024
Status verified
Dec 2025
Primary completion
May 28, 2027
Completion
May 28, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (surgical debulking, 177Lu dotatate)
    Patients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.

Primary Outcome Measure

Somatostatin receptor standardized uptake values (SSTR SUV) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37203
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Kamran Idrees, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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