- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542177
A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer
The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pancreatic cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA).
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlate FAZA PET uptake in pancreatic cancer with the extension of the disease.
Time Frame: 2 years
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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).
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2 years
|
Correlate FAZA PET uptake in pancreatic cancer with CA 19-9 levels.
Time Frame: 2 years
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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).
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2 years
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Correlate FAZA PET uptake in pancreatic cancer with tumor response.
Time Frame: 2 years
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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.
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2 years
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Correlate FAZA PET uptake in pancreatic cancer with patient disease-free survival (DFS).
Time Frame: 2 years
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Kaplan-Meier actuarial method and/or the Cox proportional hazard model will be utilized.
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2 years
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Compare the pattern of FAZA uptake in different tumor sites (eg., lymph node metastases and liver metastasis).
Time Frame: 2 years
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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.
Time Frame: 2 years
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2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Hedley, MD, Princess Margaret Hospital, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAZA-Pancreas
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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