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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

No Placebo-Only Group

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 below

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I am eligible for initial treatment with chemotherapy, possibly including radiation.

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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:

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I have a long-term lung condition.

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I have an immune system disorder, sickle cell, collagen disease, or another cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 \[MRS\]

0 / 5Eligibility criteria met