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FAZA-PET/MRI Imaging for Sarcoma
N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with 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)
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is investigating the use of FAZA-PET in combination with MRI to measure hypoxia in sarcoma tissues.
Who is the study for?
Adults with high-risk sarcoma (specific types like leiomyosarcoma or dedifferentiated liposarcoma) who are planning to undergo radiotherapy, chemotherapy, or surgery. Participants must be able to lie down for at least an hour and not be pregnant or breastfeeding. Those with previous cancer treatments or other active cancers cannot join.Check my eligibility
What is being tested?
The trial is testing FAZA-PET combined with MRI to measure oxygen levels in sarcoma tissues before treatment starts. One group will have the scan before radiation/chemotherapy, while another may have it before surgery. Some patients will also receive pimonidazole prior to surgery.See study design
What are the potential side effects?
Potential side effects from FAZA are monitored via a follow-up call two days after the PET/MRI scan. Pimonidazole's side effects will be assessed around the time of surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a high-risk soft tissue sarcoma in my limbs or a high-risk retroperitoneal sarcoma.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade of FAZA uptake in the primary tumor
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
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.
Group II: Arm AExperimental Treatment1 Intervention
Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimonidazole
Not yet FDA approved
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,140 Total Patients Enrolled
14 Trials studying Sarcoma
605 Patients Enrolled for Sarcoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment welcoming new participants?
"Affirmative. Clinicialtrials.gov states that this medical trial is actively recruiting study participants, having initially been posted on March 27th 2018 and most recently edited on October 6th 2022."
Answered by AI
To what extent are individuals participating in this research endeavor?
"Yes, according to clinicaltrials.gov the trial is still actively recruiting patients. The study was posted on March 27th 2018 and its details were last updated October 6th 2022. Currently, it seeks 30 participants from a single location."
Answered by AI
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