Pancreatic CancerNCT01542177
A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer
An observational study of Pancreatic Cancer and Hypoxia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Hypoxia
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pancreatic cancer
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Hypoxia
- Keywords
- hypoxia, pancreas, cancer, pancreatic cancer, 18F-FAZA, 18F-Fluoroazomycin Arabinoside, Positron Emission Tomography, PET
- Medical subject headings
- Pancreatic Neoplasms, Hypoxia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA).
Measured: 2 years
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 years
Determine the feasibility of using dynamic and static PET imaging of FAZA uptake in patients with pancreatic cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- David Hedley, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542177
- Sponsor's protocol ID
- FAZA-Pancreas
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2012
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Hypoxia Imaging in Patients With Pancreatic Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
- ClinicalTrials.gov ID
- NCT01542177
- Acronym / sponsor ID
- FAZA-Pancreas
- Conditions
- Pancreatic Cancer, Hypoxia
- Keywords
- hypoxia, pancreas, cancer, pancreatic cancer, 18F-FAZA, 18F-Fluoroazomycin Arabinoside, Positron Emission Tomography, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Feb 2012
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA).
Time frame: 2 years
5 secondary outcomes
Correlate FAZA PET uptake in pancreatic cancer with the extension of the disease.
Time frame: 2 years
Correlate FAZA PET uptake in pancreatic cancer with tumor response.
Time frame: 2 years
Correlate FAZA PET uptake in pancreatic cancer with patient disease-free survival (DFS).
Time frame: 2 years
Compare the pattern of FAZA uptake in different tumor sites (eg., lymph node metastases and liver metastasis).
Time frame: 2 years
Determine the feasibility of using dynamic and static PET imaging of FAZA uptake in patients with pancreatic cancer.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hedley, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Hypoxia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the hypoxia level in Patients with Pancreatic Cancer using Positron Emission Tomography (PET) with 18F-Fluoroazomycin Arabinoside (18F-FAZA). (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.