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

NCT01575951 | Completed DMC

• 1 other identifier: HCI38583
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Feasibility

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

  36 months

Secondary Outcomes (2)

• Necrosis level

  36 months

• Tumor Volume change

  36 months

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Radiation: MRI-DCE

Interventions

MRI-DCE RADIATION

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.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ying Hitchcock, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: April 12, 2012
• Study Start: February 1, 2010
• Primary Completion: November 5, 2014
• Study Completion: December 5, 2014
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)