Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FAZA | Drug | — | UNRESOLVED |
| Pimonidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.
- interventionNames
- Drug: 18F-FAZA
- type
- EXPERIMENTAL
- label
- Arm B
- description
- 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.
- interventionNames
- Drug: Pimonidazole
Primary outcomes (1)
- measure
- Grade of FAZA uptake in the primary tumor
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available