Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas

Not Applicable

Active, not recruiting

• Conditions: Sarcoma, Bone; Sarcoma, Soft Tissue; Osteosarcoma; Sarcoma, Ewing; Rhabdomyosarcoma; Non-rhabdomyosarcoma Soft-tissue Sarcoma

• Registration Number: NCT02415816
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-4-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Inclusion Criteria:<br><br> - All St Jude patients with a known or suspected, newly diagnosed bone or soft-tissue<br> sarcoma who will be treated on or as per disease specific protocols.<br><br> - Study subjects will have undergone or are scheduled for PET-CT and/or bone scan<br> within about 2 weeks of the WB and primary tumor DWI MRI.<br><br> - No limit on age or gender<br><br> - Informed consent or assent signed by study subject or parent/guardian according to<br> institutional guidelines.<br><br> - Patients should not have begun therapy, or, needed research imaging can be performed<br> within 2-5 days of starting therapy.<br><br>Exclusion Criteria:<br><br> - Subject has a tumor that will undergo upfront resection<br><br> - Subject is unable or unwilling to follow study requirements, including signed<br> consent or assent<br><br> - Subject is hospitalized in the intensive care unit.<br><br> - Subject does not meet institutional MRI safety screening requirements.<br><br> - Subject has undergone primary tumor resection prior to arrival at St. Jude.<br><br> - Subjects who require sedation for WB MRI will be excluded if they have:<br><br> - An acute cardiopulmonary process including, but not limited to, croup, reactive<br> airways disease, pneumonia, clinical or radiological evidence of pericardial<br> effusion or other cardiopulmonary disease.<br><br> - Vomiting within 24 hours of the MRI or substantial nausea that may preclude<br> sedation as determined by the anesthesiologist or certified registered nurse<br> anesthetist.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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