Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Sarcoma

Hypoxia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All Drugs and Chemicals

Fluoroazomycin arabinoside

Radiopharmaceuticals

Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.

Participants will receive pimonidazole prior to surgery. Participants in Arm B also have the option to complete a FAZA PET/MRI scan prior to surgery.

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 their radiation treatment.

18F-FAZA

Pimonidazole is a drug that will attached to areas in the tumour that are low in oxygen. When this occurs, the areas of the tumour that are low in oxygen can be more easily found and studied after surgical removal.

Pimonidazole

David Shultz, MD

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 20 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.

FAZA PET/MRI Sarcoma

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

Graded based on images from the 2-hour static scan: 0, uptake less than surrounding normal background tissues; 1, no regions of focal uptake higher than that of background; 2, focal uptake moderately higher than background; and 3, focal uptake markedly higher than background

University Health Network, Toronto

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

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.

Ali Hosni, MD

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.

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.

FAZA PET/MRI Pancreas

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)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FAZA PET/MRI Sarcoma	NCT03418818	Sarcoma	18F-FAZA Pimonidazole	18 Years -	University Health Network, Toronto
FAZA PET/MRI Pancreas	NCT04395469	Pancreatic Aden... Locally Advance... Unresectable Pa...	18F-FAZA	18 Years -	University Health Network, Toronto
FAZA PET/MRI Pancreas	NCT04395469	Pancreatic Aden... Locally Advance... Unresectable Pa...	18F-FAZA	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for faza

Every month we try and update this database with for faza cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for faza

Every month we try and update this database with for faza cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for faza cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.