Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-25 @ 5:09 PM
Study NCT ID:
NCT04609592
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2020-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Primary Objective(s)
* To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)
* To assess response rate (RR) after 2 cycles 177Lu Dotatate
* To assess recurrence free survival (RFS) of the overall treatment strategy
* To assess overall survival (OS) of the overall treatment strategy
* To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)
* To assess response rate (RR) after 2 cycles 177Lu Dotatate
* To assess recurrence free survival (RFS) of the overall treatment strategy
* To assess overall survival (OS) of the overall treatment strategy
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: