Actively Recruiting
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
Led by Stanford University · Updated on 2025-09-09
10
Participants Needed
1
Research Sites
337 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic gastroenteropancreatic neuroendocrine tumor with lymph node or liver metastases only
- WHO Grade 1 or 2 tumor with Ki 67 ≤ 20% confirmed at Stanford
- Candidate for cytoreductive surgery aiming for R1 resection as decided by a tumor board
- Measurable disease according to RECIST v1.1 criteria
- Presence of somatostatin receptors on all target lesions confirmed by 68Ga DOTA TATE PET scan
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood counts, liver, and kidney function
- On octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg every 3 to 4 weeks for at least 12 weeks before enrollment
You will not qualify if you...
- Prior treatment with 177Lu Dotatate
- Surgery or radiofrequency ablation within 12 weeks before enrollment
- Prior radioembolization, chemoembolization, or external beam radiation therapy to more than 25% of bone marrow at any time
- Chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks before enrollment
- Known brain metastases
- Known bone or peritoneal metastases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Cancer Institute Palo Alto
Stanford, California, United States, 95304
Actively Recruiting
Research Team
G
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
CONTACT
G
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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