Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-04-21 @ 10:31 PM
Study NCT ID:
NCT04713202
Status:
WITHDRAWN
Last Update Posted:
2023-02-10
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl
Sponsor:
Chandrikha Chandrasekhara
Organization:
Study Overview
Official Title:
Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funder decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NET-PACS
Brief Summary:
The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: