Pancreatic Adenocarcinoma Non-resectableNCT04395469
FAZA PET/MRI Pancreas
A study testing 18F-FAZA in people with Pancreatic Adenocarcinoma Non-resectable and Locally Advanced Pancreatic Adenocarcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Non-resectable, Locally Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer
- What is being tested?
- 18F-FAZA
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 May 2021to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- One or more of the following:
- Participants who have histologically confirmed new diagnosis of unresectable, non-metastatic, LAPAC as assessed by the multidisciplinary tumor board based on pre-RT imaging and clinical assessment, and are amenable to SBRT.
- Patients who received prior systemic therapy for unresectable LAPAC may be consented and enrolled if they still have localized unresectable LAPAC amenable to SBRT.
- Participants with newly diagnosed LAPAC who received systemic therapy for borderline resectable pancreatic adenocarcinoma and have become unresectable following preoperative multidisciplinary assessment, are eligible for the study if the patient meets the eligibility criteria based on staging following systemic therapy.
- Participants with newly diagnosed borderline resectable pancreatic adenocarcinoma.
- Age ≥18 years.
Show all 11Show fewer
- ECOG performance status ≤2 (see Appendix A).
- Life expectancy of greater than 6 months.
- A negative serum pregnancy test prior to PET-MR imaging, for women of child-bearing age.
- Ability to understand and the willingness to sign a written informed consent document.
- Eligible for treatment on the integrated magnet resonance linear accelerator (MRL).
Who cannot join
- Patients who have had prior RT to upper abdomen.
- Patients who are receiving any other concomitant investigational agents. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Patients with early stage resectable (I-II) pancreatic cancer, or known distant metastases.
- Contraindication to MRI scan as per current institutional guidelines.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because of the potential teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued.
- Patients who have a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin (other than head and neck region), or carcinoma in situ (e.g., in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded.
- History or current evidence of any condition, therapy, or laboratory abnormality, known psychiatric or substance abuse disorders that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Hypoxia and Re-oxygenation Imaging in Pancreatic Cancer Using Positron Emission Tomography (PET) With [18F] Fluoroazomycin-arabinoside (FAZA PET) and Magnetic Resonance Imaging (MRI)
This is a single arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. FAZA PET-MRI will be used to measure hypoxia in up to 20 patients with unresectable, non-metastatic, locally advanced un-resectable pancreatic adenocarcinoma (LAPAC).
After each FAZA PET-MRI scan, patients will be followed up via telephone, 48 hours after the imaging session to assure that the procedure was tolerated without side effects. Patients will undergo a FAZA PET-MRI scans before and after their standard of care radiation treatment.
Read the detailed description
The success of hypoxia-targeted therapies has so far been limited, a fact widely attributed to the absence of a reliable imaging biomarker for hypoxia that could easily be implemented into a routine clinical workflow. A compelling study has found the presence of hypoxia in pancreatic tumors using FAZA-PET imaging. The data derived from this alternative dual-imaging approach can be used to establish a patient-specific perfusion-to-hypoxia mapping, accounting for differences in tumour metabolisms. This technique was recently validated in a pre-clinical FAZA-PET/CE-MRI study of mice with orthotopically-implanted pancreatic patient-derived tumour xenografts.
The purpose of this study is to look for hypoxia in tumours using a PET scan in combination with MRI. The use of PET/MRI scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET/MRI scans can provide useful information about hypoxia in pancreatic cancer. Additionally, a recent study at the Princess Margaret Cancer Centre found varying levels of hypoxia in patients with pancreatic tumors, providing a rationale for incorporating hypoxia imaging and patient-specific treatment adaptation into the clinical management of pancreatic cancer.
- Conditions
- Pancreatic Adenocarcinoma Non-resectable, Locally Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer
- Being tested
- 18F-FAZA
- Keywords
- Hypoxia, FAZA, PET Imaging, FAZA PET MRI, locally advanced un-resectable pancreatic adenocarcinoma, Unresectable, Non-metastatic
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAZADrug
18F-FAZA is a radiotracer used for PET imaging (in combination with MRI) to detect hypoxia in tumours. This scan will be done before and after radiation treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Hypoxia
Hypoxic regions in the tumour are defined as regions for which the voxel-scale activity exceeds the mean activity in the left-ventricle blood pool by a ratio of 1.2. The fraction of such voxels in a given tumour defines the hypoxic fraction.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start18 May 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma Non-resectableStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395469
- Sponsor's protocol ID
- 19-6358
- Status last verified
- Mar 2026
- First submitted
- 15 May 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Hypoxia and Re-oxygenation Imaging in Pancreatic Cancer Using Positron Emission Tomography (PET) With [18F] Fluoroazomycin-arabinoside (FAZA PET) and Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT04395469
- Acronym / sponsor ID
- 19-6358
- Conditions
- Pancreatic Adenocarcinoma Non-resectable, Locally Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer
- Keywords
- Hypoxia, FAZA, PET Imaging, FAZA PET MRI, locally advanced un-resectable pancreatic adenocarcinoma, Unresectable, Non-metastatic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 May 2020 (actual)
- 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 single arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. FAZA PET-MRI will be used to measure hypoxia in up to 20 patients with unresectable, non-metastatic, locally advanced un-resectable pancreatic adenocarcinoma (LAPAC).
After each FAZA PET-MRI scan, patients will be followed up via telephone, 48 hours after the imaging session to assure that the procedure was tolerated without side effects. Patients will undergo a FAZA PET-MRI scans before and after their standard of care radiation treatment.
Detailed description
The success of hypoxia-targeted therapies has so far been limited, a fact widely attributed to the absence of a reliable imaging biomarker for hypoxia that could easily be implemented into a routine clinical workflow. A compelling study has found the presence of hypoxia in pancreatic tumors using FAZA-PET imaging. The data derived from this alternative dual-imaging approach can be used to establish a patient-specific perfusion-to-hypoxia mapping, accounting for differences in tumour metabolisms. This technique was recently validated in a pre-clinical FAZA-PET/CE-MRI study of mice with orthotopically-implanted pancreatic patient-derived tumour xenografts.
The purpose of this study is to look for hypoxia in tumours using a PET scan in combination with MRI. The use of PET/MRI scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET/MRI scans can provide useful information about hypoxia in pancreatic cancer. Additionally, a recent study at the Princess Margaret Cancer Centre found varying levels of hypoxia in patients with pancreatic tumors, providing a rationale for incorporating hypoxia imaging and patient-specific treatment adaptation into the clinical management of pancreatic cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- One or more of the following:
- Age ≥18 years.
- ECOG performance status ≤2 (see Appendix A).
- Life expectancy of greater than 6 months.
- A negative serum pregnancy test prior to PET-MR imaging, for women of child-bearing age.
Key exclusion criteria (8 listed)
- Patients who have had prior RT to upper abdomen.
- Patients who are receiving any other concomitant investigational agents. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Patients with early stage resectable (I-II) pancreatic cancer, or known distant metastases.
- Contraindication to MRI scan as per current institutional guidelines.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FAZA18F-FAZA is a radiotracer used for PET imaging (in combination with MRI) to detect hypoxia in tumours. This scan will be done before and after radiation treatment. | Drug | – |
Primary outcome
Tumor Hypoxia
Time frame: 2.5 years
Hypoxic regions in the tumour are defined as regions for which the voxel-scale activity exceeds the mean activity in the left-ventricle blood pool by a ratio of 1.2. The fraction of such voxels in a given tumour defines the hypoxic fraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Related trials for Pancreatic Adenocarcinoma Non-resectable
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
RecruitingPhase 2
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial
Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
Recruiting
Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer
Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FAZA in people with Pancreatic Adenocarcinoma Non-resectable and Locally Advanced Pancreatic Adenocarcinoma, 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 11 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Tumor Hypoxia (time frame: 2.5 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 5 Mar 2026.