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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/22/2018
Start Date:February 2010
End Date:March 2020

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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.

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.

Inclusion Criteria:

1. Pathologically confirmed soft tissue sarcoma.

2. Age ≥ 18.

3. ECOG 0-1.

4. Able to receive preoperative radiotherapy followed by surgical resection.

5. Able to provide treatment consent forms that conforms to federal and institutional
guidelines.

6. Have adequate kidney function for safe administration of gadolinium contrast, as
determined by current Department of Radiology MRI guidelines.

7. Creatinine clearance either by 24 hour collection or nomogram:

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:

1. Patients have claustrophobia, iron or metal in the MRI scan site or pacemaker which
are contraindicated for MRI scan.

2. patients have pacemaker or defibrillator and contraindicated to MRI images

3. Patients are allergic to gadolinium IV contrast.

4. Patients have acute or chronic renal insufficiency and contraindicated to gadolinium
contrast enhancing MRI.

5. Patient had previous radiation to the same disease site.

6. Patient had chemotherapy prior to preoperative radiotherapy.

7. Patients that are pregnant. Patients that may become pregnant must have a negative
pregnancy test prior to enrolling.
We found this trial at
1
site
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
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