NCT04609592 Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
| NCT ID | NCT04609592 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stanford University |
| Condition | Gastroenteropancreatic Neuroendocrine Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2021-03-17 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2021-03-17 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only. 2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford) 3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion 4. Measurable disease as determined by RECIST v1.1 5. Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan 6. Patients ≥ 18 years of age. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1 8. Appropriate hematologic, liver and kidney function 9. Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study Exclusion Criteria: 1. Prior 177Lu Dotatate treatment 2. 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 3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study 4. Known brain metastases 5. Known bone or peritoneal metastases
Contact & Investigator
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
✉ gpineda@stanford.edu📞 (650) 498-7757
Brendan C Visser, MD
PRINCIPAL INVESTIGATOR
Stanford Universiy
Frequently Asked Questions
Who can join the NCT04609592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroenteropancreatic Neuroendocrine Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04609592 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04609592 currently recruiting?
Yes, NCT04609592 is actively recruiting participants. Contact the research team at gpineda@stanford.edu for enrollment information.
Where is the NCT04609592 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04609592 clinical trial?
NCT04609592 is sponsored by Stanford University. The principal investigator is Brendan C Visser, MD at Stanford Universiy. The trial plans to enroll 10 participants.