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NCT04609592 · ClinicalTrials.gov registry record · Phase 1
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
A Phase 1 study of Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04609592: Recruiting Phase 1 study of Gastroenteropancreatic Neuroendocrine Tumor, sponsored by Stanford University.
NCT04609592 is a Phase 1 study of Gastroenteropancreatic Neuroendocrine Tumor that is actively recruiting participants, run by Stanford University. The registered enrollment target is 10 participants, below the 530-participant average among 7 other Gastroenteropancreatic Neuroendocrine Tumor trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04609592, a Phase 1 study of Gastroenteropancreatic Neuroendocrine Tumor, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows. * Radiation fibrosis * Hepatic fibrosis by histologic diagnosis * Hepatic insufficiency * Bowe
Conditions Studied
Interventions
- DRUG Lutathera
- DRUG Gallium 68 Dotatate
- PROCEDURE Computed Tomography (CT)
- PROCEDURE Magnetic Resonance Imaging (MRI)
- PROCEDURE PET/CT
Study Locations (1)
California
- Stanford Cancer Institute Palo Alto - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What NCT04609592 shows while recruiting
NCT04609592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 530-participant average among 7 other Gastroenteropancreatic Neuroendocrine Tumor trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Gastroenteropancreatic Neuroendocrine Tumor appearing as the primary indexed condition, and to 5 interventions - of which Lutathera is the first listed.
NCT04609592 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04609592 about?
NCT04609592 is a clinical study titled "Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery". 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 be...
What is the current status of trial NCT04609592?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-03-17. Estimated completion is 2027-09.
What conditions does trial NCT04609592 study?
This clinical trial studies the following conditions: Gastroenteropancreatic Neuroendocrine Tumor.
What interventions are being tested in trial NCT04609592?
The interventions under investigation include: Lutathera (DRUG), Gallium 68 Dotatate (DRUG), Computed Tomography (CT) (PROCEDURE), Magnetic Resonance Imaging (MRI) (PROCEDURE), PET/CT (PROCEDURE).
Who is sponsoring clinical trial NCT04609592?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04609592 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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