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Hypoxia Imaging Techniques for Soft Tissue Sarcoma
Phase 1
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy
Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma [RMS] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component
Must not have
Patients with chronic pulmonary disease
Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial will test the feasibility of using existing and novel imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas.
Who is the study for?
This trial is for children and adolescents aged 7-18 with suspected or confirmed sarcoma tumors who are candidates for standard chemotherapy, possibly with radiation. It's not suitable for those with other diagnoses, MRI contraindications like metal implants, no need for neoadjuvant therapy, immunodeficiency diseases, another cancer type, or chronic lung disease.
What is being tested?
The study tests imaging technologies to measure tumor hypoxia in pediatric soft tissue sarcomas. It compares BOLD MRI, DW MRI, MRS and 18F-FAZA PET-MRI against conventional MRI to assess response to therapy before surgery.
What are the potential side effects?
Since the interventions are diagnostic imaging techniques rather than drugs or surgeries, side effects may include discomfort during the scan process or reactions related to contrast agents used (if any), such as mild allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for initial treatment with chemotherapy, possibly including radiation.
Select...
I have been diagnosed or suspected to have a sarcoma tumor with a part growing outside the bone.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long-term lung condition.
Select...
I have an immune system disorder, sickle cell, collagen disease, or another cancer.
Select...
I am not recommended to have treatment before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with response to therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: FAZA - BOLD- DW- MRSExperimental Treatment4 Interventions
18F-FAZA (F18-Fluoroazomycin Arabinoside) is a radioactive agent developed as a non-invasive probe for the assessment of cellular hypoxia. 18F-FAZA Injection is indicated in a single dose of (5.2 MBq/kg \[0.14 mCi/kg\]) Route/method of administration: intravenous injection.
Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI, MR Spectroscopy \[MRS\]
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,859 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term lung condition.I am eligible for initial treatment with chemotherapy, possibly including radiation.You cannot have an MRI scan due to having metal in your body, a pacemaker, or not being able to stay still during the scan without sedation.I have an immune system disorder, sickle cell, collagen disease, or another cancer.I have been diagnosed or suspected to have a sarcoma tumor with a part growing outside the bone.You have been diagnosed with a different condition after being initially suspected of having RMS or non-RMS.I am not recommended to have treatment before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: FAZA - BOLD- DW- MRS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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