A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Pancreatic Adenocarcinoma, Advanced Disease, Metastatic Disease

Intervention / Treatment
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* Drug: 18F-Fluoroazomycin arabinoside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study Age 18 years or older Cytologic/histologic diagnosis of pancreatic adenocarcinoma Advanced stage pancreatic cancer: locally advanced or metastatic. No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed > 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed. ECOG performance status 1 or less Adequate end organ and marrow function Measureable or non-measureable disease by RECIST 1.1 Female patients of child-bearing potential must have a negative serum pregnancy test (BhCG) and must agree to abstinence or use adequate contraception for the duration of the study Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) breast disease). Ability to provide written informed consent Must be able to lie flat comfortably for 30 to 60 min to complete imaging study Exclusion Criteria: Inability to lie supine for 30 to 60 minutes Concurrent second primary Life expectancy of less than 12 weeks On treatment with disulfiram (antabuse) due to [18F]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAZA PET-CT scan<br>FAZA PET-CT imaging within 14 days of treatment from the EMR200592-001 study. FAZA PET-CT imaging about 5 weeks after start of treatment from the EMR200592-001 study. | Drug: 18F-Fluoroazomycin arabinoside<br> <br> * Other names: [18F] FAZA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expected number of similar quality scans produced compared to actual number of similar quality scans produced using the same method is less than 15%. |  | 2 years | 
| Number of enrolled patients that complete all required scans compared to total number of patients enrolled in the study is at least 70%. |  | 2 years | 
| Range of tumor hypoxia in patients with pancreatic cancer that had not received prior treatment. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the changes in tumor hypoxia before chemotherapy treatments and after chemotherapy treatments. |  | 2 years | 
| Compare the changes in tumor hypoxia with response to chemotherapy treatments. |  | 2 years | 
| Evaluate how FAZA is taken in by different tumor types within individual patients. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, 18F-FAZA, 18F-Fluoroazomycin arabinoside, Positron emission tomography, PET, Participating in study EMR200592-001