Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma
The purpose of this study is to investigate the ability of advanced quantitative imaging techniques to determine osteogenic tumor response. It is anticipated that the uptake and accumulation of [18F] Fluoro-L-thymidine ([18F]-FLT)will decrease in patients with osteosarcoma after one cycle of neoadjuvant chemotherapy (NAC). Furthermore, it is believed that the decrease in [18F]- (FLT) uptake, after one cycle of NAC, will significantly correlate with a decrease in tumor size and/or volume after two cycles of NAC.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma|
- Percent change in MRI metrics [ Time Frame: Pre-treatment and end of neoadjuvant cycle 1 ] [ Designated as safety issue: No ]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.
- Percent change in Standard Uptake Value from 18F-FLT-PET/CT [ Time Frame: Pre-treatment and at end of cycle 1 of neoadjvuant chemotherapy. ] [ Designated as safety issue: No ]employ [18F]-FLT-PET/CT to quantitatively measure tumor cell proliferation within osteogenic tumors before and after the first cycle of NAC with cisplatin/ doxorubicin/methotrexate.
- Progression-free survival [ Time Frame: From first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
dynamic CE and DW MRI, PET/CT-[18F]-fluorodeoxyglucose
Patients will have dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging modalities and/or integrated positron emission tomography/computerized tomography with [18F]-fluorodeoxyglucose studies performed before and after 1 cycle of chemotherapy.
Imaging techniques using high-field MRI to make quantitative assessments
Other Name: dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging modalitiesOther: PET/CT
Radiologic imaging techniques PET using [18F]-fluorodeoxyglucose as a tracer for PET to provide metabolic information together with CT scanning to provide anatomic information
Other Name: integrated positron emission tomographywith [18F]-fluorodeoxyglucose/computerized tomography
Patients with known osteosarcoma who are scheduled to receive neoadjuvant chemotherapy (NAC) will be enrolled on either the multi-parametric MRI component or the [18F]-FLT-PET/CT component, or both. In each component, each patient will undergo two separate scanning sessions at the following time points: 1) prior to the initiation of NAC; and 2) on Cycle 2 Day 1 (± 3 days) of NAC.
|Contact: VICC Clinical Trials Information Program||800-811-8480|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: VICC Clinical Trials Information Program|
|Principal Investigator: Vicki Keedy, MD|
|Principal Investigator:||Vicki Keedy, MD||Vanderbilt-Ingram Cancer Study|