FAZA PET/MRI Pancreas

NCT04395469 | Active Not Recruiting

• 1 other identifier: 19-6358
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2.5 years

Interventions

18F-FAZA DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One or more of the following:
• A) 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.
• B) Patients who received prior systemic therapy for unresectable LAPAC may be consented and enrolled if they still have localized unresectable LAPAC amenable to SBRT.
• C) 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.
• D) Participants with newly diagnosed borderline resectable pancreatic adenocarcinoma.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.
• Eligible for treatment on the integrated magnet resonance linear accelerator (MRL).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

MeSH Terms

Conditions

Hypoxia

Interventions

fluoroazomycin arabinoside

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: May 18, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)