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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a St Jude patient with a new diagnosis of bone or soft-tissue sarcoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at diagnosis (day 0 within about 5 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at diagnosis (day 0 within about 5 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Event free survival)
Overall survival
Primary tumor ADC values for FDG SUVmax values
+7 moreTrial 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.
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Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,515 Total Patients Enrolled
Mary E. McCarville, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
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Eligibility Criteria:
This trial includes the following eligibility 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.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.I am currently in the intensive care unit.I had surgery to remove my primary tumor before coming to St. Jude.I am a St Jude patient with a new diagnosis of bone or soft-tissue sarcoma.I haven't vomited or felt severe nausea in the last 24 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being enrolled for this experiment?
"The information contained on clinicaltrials.gov indicates that this research is no longer recruiting candidates, the initial posting was in June 2015 and it had its most recent update in April 2022. Nevertheless, there are presently 517 other studies looking for participants."
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