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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Feasibility

Outcome Description:

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

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Ying Hitchcock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

HCI38583

NCT ID:

NCT01575951

Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Soft Tissue Sarcoma
  • Sarcoma

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112