Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Whole body (WB) and primary tumor diffusion weighted imaging (DWI) will be performed at baseline in all subjects. Additional DW-MRIs will be done up to 3 times during treatment at the same time as routine MRI examinations are scheduled. Follow-up primary tumor DWI MRI examinations will be performed at time points determined by the participant's therapeutic treatment protocol. Follow-up primary tumor DWI examinations will be performed until completion of local control (surgical resection or completion of radiation therapy). All examinations will be performed on 1.5T Siemens magnetic resonance (MR) scanners unless there is a clinical indication for 3T imaging. Because investigators will correlate imaging parameters with patient outcome, participants will be followed until they are discharged to the After Completion of Therapy Clinic or until they have tumor progression or recurrence or develop a second malignancy or death, whichever comes first. PRIMARY OBJECTIVES: - To estimate the proportion of pediatric sarcoma patients whose bone/bone marrow and soft-tissue metastasis status are correctly staged by whole body diffusion weighted MRI (WB DWI) at the time of diagnosis by comparing it to clinical stage. - To determine the correlation between changes in primary pediatric sarcoma 18F-fluorodeoxyglucose positron emission tomography (FDG PET) maximum standardized uptake values (SUVmax) and average DWI apparent diffusion coefficient (ADC) values from baseline (pre-treatment) to just prior to local control. OTHER PRESPECIFIED OBJECTIVES: - To estimate the sensitivity, specificity, accuracy, and negative and positive predictive values of WB DWI, PET-CT and PET-CT + bone scan for detecting sites of metastatic tumor in pediatric sarcomas using biopsy or clinical follow-up (including imaging studies and clinical information) as the reference standards. - To compare the ability of WB MRI, PET-CT and PET-CT + bone scan to detect all sites of metastases in pediatric sarcoma patients using biopsy and clinical judgment as the reference standards. - To examine the associations of DWI ADC values of primary tumors at diagnosis and treatment protocol driven time points during therapy with tumor histology, tumor grade, RECIST response, % tumor necrosis, FDG SUVmax and patient outcome. - To compare whole body DWI to conventional T1W and STIR whole body MRI for the detection of nodal, bone/bone marrow, soft-tissue or lung metastases among pediatric bone and soft-tissue sarcoma patients using biopsy and clinical judgment as the reference standards. - To investigate the value of a variety of quantitative parameters obtained from software analysis of the primary tumor, such as; histogram kurtosis, range, peak, shifts in peak, or tumor heterogeneity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02415816
Study type Interventional
Source St. Jude Children's Research Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date June 5, 2015
Completion date April 2027

See also
  Status Clinical Trial Phase
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT02383901 - A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX N/A
Active, not recruiting NCT01758666 - A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy N/A
Completed NCT01674101 - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy N/A
Completed NCT01615640 - Diffusion Study on Patients With Osteosarcoma
Completed NCT00523419 - Chemotherapy for Patients With Osteosarcoma Phase 2
Completed NCT00520936 - A Study of Pemetrexed in Children With Recurrent Cancer Phase 2
Completed NCT00132158 - ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Not yet recruiting NCT04319874 - Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma Phase 2
Recruiting NCT06029218 - Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy N/A
Recruiting NCT05642455 - SPEARHEAD-3 Pediatric Study Phase 1/Phase 2
Recruiting NCT06117878 - Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma Early Phase 1
Not yet recruiting NCT04316091 - A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma Phase 1
Recruiting NCT03932058 - Proteomics Research of Osteosarcoma
Withdrawn NCT01236586 - RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia Phase 1
Completed NCT00743496 - A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma Phase 1
Recruiting NCT04040205 - Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration Phase 2
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03628209 - Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma Phase 1/Phase 2