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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 30 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Patients with either: high-risk extremity STS (g2-3, \> 10 cm largest dimension, and leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumour, or undifferentiated pleomorphic sarcoma), or: high-risk RPS (g2-3, and leiomyosarcoma or dedifferentiated liposarcoma)

• Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM

• A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age

• Ability to provide written informed consent to participate in the study

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Time Frame
Start Date: 2018-03-27
Estimated Completion Date: 2028-10
Participants
Target number of participants: 50
Treatments
Experimental: Arm A
Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.
Experimental: Arm B
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.
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov