Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
NCT Number: NCT01575951
This is a pilot study to determine the diagnostic value of dynamic contrast enhancing MRI (DCE-MRI) in soft tissue sarcoma for assessment of tumor radiographic changes in vascular permeability and microvessel density before and after preoperative radiotherapy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84112, United States
All patients have biopsy proven soft tissue sarcoma and undergo preoperative radiotherapy. Dynamic contrast-enhancing MRI T1-weight DCE-MRI will cover the whole tumor and involved lymph nodes if indicated. DCE-MRI is obtained before radiation starts and 4 weeks after RT completes. Blood volume images are estimated by using general Toft model, by which the blood flow was corrected for vascular permeability and perfusion. These images are geometrically co-registered with post-Gd T1-weighted MR images and pre-op RT routine MRI images are fused with the treatment planning CT.
Routine and DCE-MRI will be evaluated in each patient to determine the gross tumor volume. The quantitative parameters are determined on DCE-MRI for quantitative parameters in blood flow and permeability in the region of interest. Dynamic images are converted into color maps reflecting Ktrans, kep, Ve, and mean value of each parameter.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Creatinine clearance (CC) > 50 ml/min is determined by 24 hour collection or nomogram: CC male = (140 - age) x (wt. in kg)/(Serum Cr mg/dl) x 72 CC female = 0.85 x (CC male)
Exclusion criteria
The treatment follows the standard practice including radiation dose and treatment volumes.
DCE-MRI imaging is to be performed immediately after CT simulation using the same immobilization device.
Pre-op DCE-MRI is performed and integrated into radiation simulation planning which is considered a standard technique for radiation oncologist to assess tumor volume and peritumoral edma. It will make radiation field more accurate and precise. This MRI is to be performed on the date of simulation immediately after CT simulation.
MRI image data is then transferred into radiation eclipse system, and integrated into the planning system for target contouring.
Follow the standard pre-operative radiotherapy technique using 3D conformal radiotherapy (3DCRT) or intensity modulated radiation therapy (IMRT) to deliver a total dose of 50 Gy at 2 Gy per fraction for trunk or extremity STS, or 45 Gy at 1.8 Gy per fraction for retroperitoneal STS, 5 treatments per week.
Time frame: 36 months
Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma
Time frame: 36 months
We will measure necrosis within the ROI (region of interest).
Time frame: 36 months
We will measure tumor volume change of tissues within the ROI (region of interest).
University of Utah
Other
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