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Hypoxia Imaging Techniques for Soft Tissue Sarcoma

Q: How hazardous is BOLD MRI to the health of volunteers?

<p>Due to the restricted data available on BOLD <a href="https://www.withpower.com/clinical-trials/mri">MRI</a>'s safety and efficacy, our team rated its security a 1 out of 3.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with response to therapy

Secondary outcome measures

Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,775 Total Patients Enrolled

Media Library

Blood Oxygen Level Dependent [BOLD] MRI Clinical Trial Eligibility Overview. Trial Name: NCT03054792 — Phase 1

Soft Tissue Sarcoma Research Study Groups: FAZA - BOLD- DW- MRS

Soft Tissue Sarcoma Clinical Trial 2023: Blood Oxygen Level Dependent [BOLD] MRI Highlights & Side Effects. Trial Name: NCT03054792 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly individuals aged 85 or above meet the criteria to partake in this trial?

"This research is seeking participants aged between 6 and 18 years old."

Answered by AI

Is this clinical trial still open to enrolment?

"This medical study is no longer accepting participants, having been initially posted on May 1st 2017 and last edited November 24th 2021. Those seeking clinical trial opportunities can find 625 trials actively recruiting patients with rhabdomyosarcoma and one Blood Oxygen Level Dependent [BOLD] MRI that needs volunteers."

Answered by AI

How many participants is this clinical trial recruiting?

"Unfortunately, this clinical trial has stopped accepting participants. As per the information on clinicialtrials.gov, it was initially posted in May 2017 and last updated November 2021. If you're looking for other studies to participate in, there are currently 625 trials recruiting patients with rhabdomyosarcoma and 1 study that requires BOLD MRI data from volunteers."

Answered by AI

Are there any historical accounts of the utilization of BOLD MRI in research?

"As of now, 1 clinical trial involving Blood Oxygen Level Dependent [BOLD] MRI is underway; however, none of these trials have progressed to the Phase 3 stage yet. Toronto, Ontario has a majority of research sites running experiments with this treatment while one other location is testing it as well."

Answered by AI

Am I eligible to partake in this empirical research?

"Eligible participants for this trial must have rhabdomyosarcoma and be within the age bracket of 6 to 18 years old. So far, a total of 18 patients are needed to take part in the study."

Answered by AI