Pilot Study: Dynamic Contrast-enhanced Magnetic Resonance Imaging(DCE-MRI)for Assessing Tumor Vascularity and Permeability in Soft Tissue Sarcoma Treated With Preoperative Radiotherapy Followed by Surgical Resection
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|ClinicalTrials.gov Identifier: NCT01575951|
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Radiation: MRI-DCE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Dynamic Contrast-enhanced Magnetic Resonance Imaging(DCE-MRI)for Assessing Tumor Vascularity and Permeability in Soft Tissue Sarcoma Treated With Preoperative Radiotherapy Followed by Surgical Resection|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||November 5, 2014|
|Actual Study Completion Date :||December 5, 2014|
Experimental: All patients
All participants enrolled.
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.
- Feasibility [ Time Frame: 36 months ]Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma
- Necrosis level [ Time Frame: 36 months ]We will measure necrosis within the ROI (region of interest).
- Tumor Volume change [ Time Frame: 36 months ]We will measure tumor volume change of tissues within the ROI (region of interest).
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): NCT01575951
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Ying Hitchcock, MD||Huntsman Cancer Institute|