COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575951
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Radiation: MRI-DCE Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All patients
All participants enrolled.
Radiation: MRI-DCE

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.





Primary Outcome Measures :
  1. Feasibility [ Time Frame: 36 months ]
    Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma


Secondary Outcome Measures :
  1. Necrosis level [ Time Frame: 36 months ]
    We will measure necrosis within the ROI (region of interest).

  2. Tumor Volume change [ Time Frame: 36 months ]
    We will measure tumor volume change of tissues within the ROI (region of interest).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Ying Hitchcock, MD Huntsman Cancer Institute
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01575951    
Other Study ID Numbers: HCI38583
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms