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
Sponsors and collaborators
Stanford University
Lead sponsor
Novartis Pharmaceuticals
Collaborator