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A Prospective Study of Hypoxia Imaging in Patients With Soft Tissue Sarcoma Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA) in Combination With MRI
This is a dual 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 sarcoma tissues and will occur for: Arm A: before neo-adjuvant radiation/chemotherapy treatment; Arm B: before surgery (optional). After the FAZA PET/MRI scan, patients will be followed up via telephone, 48 hours after the scan, to see if there are any side effects due to FAZA. Up to 50 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.
Mutliple studies show that hypoxia in sarcoma has been consistently associated with poor treatment outcomes. Subsequently, there has been a study that shows inhibition of hypoxia-induced transcription factor (HIF-1 alpha), with radiation, was effective in disease treatment in pre-clinical models. This shows how important hypoxia was in playing a role in overall disease outcome and survival. As a means of examining tumor features, such as hypoxia, hybrid PET/MR imaging combines the advantages of MRI's soft-tissue and contrast resolution with PET's functional metabolic capabilities. There have been few reports of using 18F-FDG in diagnostic PET/MRI. with the use of 18F-FAZA in this study, parameters such as diffusion, micro-perfusion, and contrast enhancement (as a surrogate marker for viable tumour tissue) can be simultaneously compared with the FAZA-derived pattern, in a single procedure. The study is being conducted to measure the volume of hypoxic tumor in high-risk STS patients, using FAZA-PET/MRI, before and after neoadjuvant radiotherapy/chemotherapy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Health Network
Toronto, Ontario, Canada
Start Date
March 27, 2018
Primary Completion Date
October 1, 2028
Completion Date
October 1, 2028
Last Updated
March 6, 2026
70
ESTIMATED participants
18F-FAZA
DRUG
Pimonidazole
DRUG
Lead Sponsor
University Health Network, Toronto
NCT04704661
NCT06066138
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