A Study Using 18F-FAZA And PET Scans To Study Hypoxia In Pancreatic Cancer

Study Overview

A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer

This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET). Hypoxia can influence how pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic cancer. Also as part of the study, a blood sample will be taken to study biomarkers (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer) that may be useful in studying pancreatic cancer and hypoxia.

This is a single centre, single arm hypoxia study of pancreatic cancer with PET FAZA imaging. PET-CT imaging of tumor hypoxia with FAZA will be done prior to the start of standard treatment for pancreatic cancer with chemotherapy. The FAZA PET-CT imaging session will last approximately 2.5 hours and include an initial dynamic scan to completely characterize the initial rapid phase of FAZA uptake, followed by a later static scan.

Pancreatic Cancer
Hypoxia

FAZA-Pancreas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-01-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-05-04
First Submitted that Met QC Criteria 2012-03-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-05-05
First Posted (ACTUAL) 2012-03-02	Results First Posted N/A	Last Verified 2022-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Pancreatic cancer

Primary Outcome Measures	Measure Description	Time Frame
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA).		2 years

Secondary Outcome Measures	Measure Description	Time Frame
Correlate FAZA PET uptake in pancreatic cancer with the extension of the disease.	Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD).	2 years
Correlate FAZA PET uptake in pancreatic cancer with CA 19-9 levels.	Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD). These parameters will be correlated with increasing or decreasing CA 19-9 levels (U/ml).	2 years
Correlate FAZA PET uptake in pancreatic cancer with tumor response.	Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD). Tumor response is measured in millimeters. Complete response is a tumor reduction of <5 mm, partial response is at least a 30% reduction, progressive disease is a 20% increase, and stable disease is no increase in shrinkage and no increase in growth.	2 years
Correlate FAZA PET uptake in pancreatic cancer with patient disease-free survival (DFS).	Kaplan-Meier actuarial method and/or the Cox proportional hazard model will be utilized.	2 years
Compare the pattern of FAZA uptake in different tumor sites (eg., lymph node metastases and liver metastasis).	Standardized uptake statistics will be calculated for each volume of interest (VOI): Maximum standardized uptake value (SUVMax), mean standardized uptake value (SUVMean) and standard deviation of standardized uptake values (SUVSD).	2 years
Determine the feasibility of using dynamic and static PET imaging of FAZA uptake in patients with pancreatic cancer.		2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Minimum age of 18 years old
Histologic diagnosis of pancreatic adenocarcinoma
TNM (7th edition) cT1-4, N0-1, M0-1
No cytotoxic anti-cancer therapy for advanced / metastatic pancreatic cancer prior to study entry
Ability to provide written informed consent to participate in the study
ECOG performance status 0, 1 or 2.
Patient should have the following blood counts at baseline: ANC equal or greater to 1.5 x 109/L; Platelets equal or greater to 100 x 109/L; Hgb equal or greater to 9g/Dl
Patient should have the following blood chemistry levels at baseline: AST (SGOT), ALT (SGPT) equal or less than 5 x upper limit of normal range (ULN) is allowed
Patient has an identifiable tumor (pancreatic tumor and/or metastasis) by imaging (CT scan and/or MR)
Patient must agree to use contraception considered adequate and appropriate by the investigator and if the patient is female of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (B-hCG)

Inability to lie supine for more than 30 minutes
Any other type of primary cancer
Life expectancy of less than 12 weeks
Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart)
Patient has serious medical risk factors involving any of the major organ systems

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Canadian Cancer Society (CCS)

Investigators

PRINCIPAL_INVESTIGATOR: David Hedley, MD, Princess Margaret Hospital, Canada

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record