BIQSFP-COG AALL1131 11XS198 Per-Case Reimbursement

  • Wagner, Lars (PI)
  • Greenwood Cassidy, Martha (Former PI)

Grants and Contracts Details


This optional ancillary study aims to determine the incidence and natural history of radiologic osteonecrosis (ON) without clinical symptoms (silent ON). MRI has been proven to be a highly sensitive diagnostic tool for ON, allowing the earliest and most accurate diagnosis. This study will utlize serial screening MRIs of both hips and knees to determine how often silent ON progresses to subchondral collapse. It will also seek to determine independent prognostic factors for subchondral collapse and if exposure to asparaginase (ASNase) and methotrexate (MTX) are risk factors on developing ON. Screening/research MRIs of hips and knees without contrast will be performed at 3 time points to determine the presence or absence of ON, sites of involvement and extent of disease. Symptoms will be assessed prior to each MRI using a standardized form (available on the AALL1131 protocol webpage under "Data Collection/Speciments"). As patients must be at least 10 years old, sedation should not be needed and is not covered by this study. Central radiology review will be performed after each of the MRIs and in instances when disease has progressed or subchondral facture has developed, comparison will be made with the site imaging report, if available. Central review will be batched and read on a regular basis, but will not be returned to sites. Diagnostic MRIs can be performed as needed at other time points based on clinical symptoms. The second portion of this study addresses the role of ASNase and MTX exposure in the development of ON. All blood draws for these optional studies occur at the time of scheduled visits for chemotherapy. All study labs are performed at St Jude Childrens Research Hospital and there is not cost to local centers for lab tests or shipping. Please see Appendix IB of the protocol for details regarding blood sample collection and shipment for the optional bllod draw portion of this study. Funding for the MRIs will be provided as $667 per study (total 3 studies) to be reimbursed on a quarterly basis after the studies have been completed.
Effective start/end date3/20/129/30/16


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