Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-08 @ 11:01 AM
Study NCT ID:
NCT02496832
Status:
WITHDRAWN
Last Update Posted:
2018-02-19
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
An Exploratory Study of Hypoxia Imaging Using 18F-FAZA-PET in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine + TH-302/Placebo (MAESTRO: EMR200592-001)
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.
This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.
The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.
This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.
The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: