18F-FAZA: 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.
Pimonidazole: 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.
Study 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 50 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years
2. 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)
3. Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM
4. A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age
5. Ability to provide written informed consent to participate in the study
Exclusion Criteria:
1. Previous radiotherapy to intended treatment volumes.
2. Previous systemic therapy
3. Active malignancy other than sarcoma
4. Unable to remain supine for at least 60 minutes
5. Pregnancy or breast feeding
6. Age less than 18 years old
7. Failure to provide written informed consent
8. Contraindication for MR as per current institutional guidelines.
Primary outcome measure(s)
Grade of FAZA uptake in the primary tumor — 2 years 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
Trial sites (1)
Facility
City
Region
Status
University Health Network
Toronto
Ontario
More University Health Network, Toronto trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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