Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma
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|ClinicalTrials.gov Identifier: NCT01882231|
Recruitment Status : Terminated (Slow accrual and lack of funding)
First Posted : June 20, 2013
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Paget's Disease Ewing Sarcoma||Other: DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||April 25, 2016|
|Actual Study Completion Date :||April 25, 2016|
DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI
Patients will have dynamic contrast-enhanced (DCE), diffusion-weighted (DW), magnetization transfer (MT), and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI) performed before and after 1 cycle of chemotherapy.
Other: DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI
Imaging techniques using high-field MRI to make quantitative assessments in patients with osteosarcoma or Ewing sarcoma
- Percent change in MRI metrics [ Time Frame: Pre-treatment and end of neoadjuvant cycle 1 ]Use 3T CEST-MRI, DW-MRI, and DCE-MRI to quantitatively measure protein content (APTasym), tumor cellularity (ADC), and tumor perfusion (Ktrans)and measure changes in these parameters from baseline to post 1 cycle of neoadjuvant chemotherapy.
- Progression-free survival [ Time Frame: From first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death ]Duration from first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death for any reason
- Percent of tumor necrosed at surgical resection [ Time Frame: At surgical resection, post-cycle 3 of neoadjuvant chemotherapy, or post-cycle 2 if tumor has progressed. ]Percent of necrosis in the excised tumor specimen determined by the reading pathologist.
- Percent change in tumor size [ Time Frame: Pre-treatment and at the end of cycle 2 of neoadjuvant chemotherapy ]Standard of care imaging, either CT or MRI, will be performed prior to the initiation of neoadjuvant chemotherapy and at the end of cycle 2 using standard RECIST 1.1 guidelines summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882231
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Vicki Keedy, MD||Vanderbilt-Ingram Cancer Study|