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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lutathera
  • Gallium 68 Dotatate
  • Computed Tomography (CT)
  • Magnetic Resonance Imaging (MRI)
  • PET/CT

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Stanford University

Lead sponsor

Novartis Pharmaceuticals

Collaborator