Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT04395469
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.
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:
NCT04395469
Study Brief:
Protocol Section:
NCT04395469