DW-MRI for Sarcoma in Young Patients

Recruiting in Palo Alto (17 mi)

Overseen byMary E. McCarville, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

Children with sarcomas are routinely assessed with a variety of imaging techniques that involve the use of ionizing radiation. These include computed tomography (CT), nuclear bone scan, and positron emission tomography-CT (PET-CT). Pediatric sarcoma patients undergo many imaging studies at the time of diagnosis, during therapy and for years following completion of therapy. Because children are in a stage of rapid growth, their tissues and organs are more susceptible to the harmful effects of ionizing radiation than are adults. Furthermore, compared to adults, children have a longer life expectancy and, therefore, a longer period of time in which to develop the adverse sequelae of radiation exposure, such as the development of second malignancies. Alternative experimental methods of measuring tumor response will be compared to current standard of care measures to determine if the experimental method is equivalent to methods currently being used. Investigators wish to determine if they can reduce patient's exposure to the harmful effects of ionizing radiation by replacing imaging studies that use radiation with whole body diffusion weighted magnetic resonance imaging (DW-MRI) which does not use any radiation. They also want to know if DW-MRI measurements of the tumor can tell how well the tumor is responding to therapy. There have been studies in adults with cancer that have shown that DW-MRI provides useful information about how tumors are responding to therapy. There have only been very small studies of DW-MRI in children with tumors in the body. Therefore, the role of DW-MRI in pediatric sarcoma patients is not yet known and it is still experimental. This study might give us important information that could help us treat other children with bone or soft tissue sarcomas in the future.

Research Team

Mary E. McCarville, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have had or will have a PET-CT or bone scan within 2 weeks of my MRI.

My age or gender does not affect my eligibility.

Informed consent or assent signed by study subject or parent/guardian according to institutional guidelines

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Exclusion Criteria

Subject does not meet institutional MRI safety screening requirements

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

My tumor is scheduled for surgical removal soon.

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Treatment Details

Interventions

Diffusion Weighted Magnetic Resonance Imaging (Procedure)

Trial OverviewThe 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.

Participant Groups

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.