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DW-MRI for Sarcoma in Young Patients

N/A

Waitlist Available

Led By Mary E. McCarville, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All St Jude patients with a known or suspected, newly diagnosed bone or soft-tissue sarcoma who will be treated on or as per disease specific protocols

Must not have

Subjects who require sedation for WB MRI will be excluded if they have: An acute cardiopulmonary process including, but not limited to, croup, reactive airways disease, pneumonia, clinical or radiological evidence of pericardial effusion or other cardiopulmonary disease

Subject has a tumor that will undergo upfront resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at diagnosis (day 0 within about 5 days) and at protocol driven time points up to 18 weeks (time of local control).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a method that doesn't involve radiation (DW-MRI) can be used instead of current methods (CT, nuclear bone scan, PET-CT) to measure how well children with sarcomas are responding to therapy, in order to reduce exposure to harmful effects of ionizing radiation.

Who is the study for?

This trial is for young patients at St. Jude with newly diagnosed bone or soft tissue sarcomas who haven't started treatment yet. They must have had or be scheduled for a PET-CT/bone scan and can undergo MRI within 2-5 days of starting therapy. It's not for those needing immediate tumor resection, ICU patients, those unable to meet MRI safety requirements, or if sedation is risky due to certain health conditions.

What is being tested?

The study tests whether whole body diffusion weighted magnetic resonance imaging (DW-MRI), which doesn't use harmful radiation, can effectively measure tumor response in pediatric sarcoma patients compared to current methods that do use radiation.

What are the potential side effects?

Since DW-MRI does not involve ionizing radiation like CT or PET scans, it avoids the associated risk of developing second malignancies from exposure. There are no direct side effects from the DW-MRI itself being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a St Jude patient with a new diagnosis of bone or soft-tissue sarcoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any current heart or lung conditions that would prevent me from safely receiving sedation for an MRI.

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My tumor is scheduled for surgical removal soon.

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I am currently in the intensive care unit.

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I had surgery to remove my primary tumor before coming to St. Jude.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at diagnosis (day 0 within about 5 days) and at protocol driven time points up to 5 years after the end of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at diagnosis (day 0 within about 5 days) and at protocol driven time points up to 5 years after the end of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at diagnosis (day 0 within about 5 days) and at protocol driven time points up to 5 years after the end of therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with pediatric sarcomas whose bone/bone marrow and soft-tissue metastasis status is correctly staged with whole body DWI MRI

The primary tumor DWI ADC and FDG PET SUVmax values at baseline and protocol driven time points up until local control

Other study objectives

Event free survival)

Overall survival

Primary tumor ADC values for FDG SUVmax values

+7 more

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: ParticipantsExperimental Treatment1 Intervention

All patients who consent to participate in this protocol. They will have diffusion weighted magnetic resonance imaging performed at several time points.

0 / 5Eligibility criteria met