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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

Primary Purpose

Soft Tissue Sarcoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI-DCE

About this trial

This is an interventional screening trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed soft tissue sarcoma.
Age ≥ 18.
ECOG 0-1.
Able to receive preoperative radiotherapy followed by surgical resection.
Able to provide treatment consent forms that conforms to federal and institutional guidelines.
Have adequate kidney function for safe administration of gadolinium contrast, as determined by current Department of Radiology MRI guidelines.
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:

Patients have claustrophobia, iron or metal in the MRI scan site or pacemaker which are contraindicated for MRI scan.
patients have pacemaker or defibrillator and contraindicated to MRI images
Patients are allergic to gadolinium IV contrast.
Patients have acute or chronic renal insufficiency and contraindicated to gadolinium contrast enhancing MRI.
Patient had previous radiation to the same disease site.
Patient had chemotherapy prior to preoperative radiotherapy.
Patients that are pregnant. Patients that may become pregnant must have a negative pregnancy test prior to enrolling.

Sites / Locations

Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

All participants enrolled.

Outcomes

Primary Outcome Measures

Feasibility

Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma

Secondary Outcome Measures

Necrosis level

We will measure necrosis within the ROI (region of interest).

Tumor Volume change

We will measure tumor volume change of tissues within the ROI (region of interest).

Full Information

NCT ID

NCT01575951

First Posted

January 30, 2012

Last Updated

April 23, 2020

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT01575951

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

November 5, 2014 (Actual)

Study Completion Date

December 5, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All patients

Arm Type

Experimental

Arm Description

All participants enrolled.

Intervention Type

Radiation

Intervention Name(s)

MRI-DCE

Intervention Description

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 Measure Information:

Title

Feasibility

Description

Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Necrosis level

Description

We will measure necrosis within the ROI (region of interest).

Time Frame

36 months

Title

Tumor Volume change

Description

We will measure tumor volume change of tissues within the ROI (region of interest).

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed soft tissue sarcoma. Age ≥ 18. ECOG 0-1. Able to receive preoperative radiotherapy followed by surgical resection. Able to provide treatment consent forms that conforms to federal and institutional guidelines. Have adequate kidney function for safe administration of gadolinium contrast, as determined by current Department of Radiology MRI guidelines. 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: Patients have claustrophobia, iron or metal in the MRI scan site or pacemaker which are contraindicated for MRI scan. patients have pacemaker or defibrillator and contraindicated to MRI images Patients are allergic to gadolinium IV contrast. Patients have acute or chronic renal insufficiency and contraindicated to gadolinium contrast enhancing MRI. Patient had previous radiation to the same disease site. Patient had chemotherapy prior to preoperative radiotherapy. Patients that are pregnant. Patients that may become pregnant must have a negative pregnancy test prior to enrolling.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying Hitchcock, MD

Organizational Affiliation

Huntsman Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

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