Study of Low Dose CT in Sarcoma Patients

Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma

The primary outcome of this study is the detection of lung metastases comparing Low dose CT (LDCT) and Minimum dose CT (MnDCT) with CXR.

Hypothesis

1. LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).
2. MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Procedure: low dose CT

Detailed Description

A 3-year prospective phase II non-randomized study commenced May 2003 enrolling 60 high-risk patients with Intermediate and High Grade STS. Each patient is kept under radiological surveillance for 3 years unless lung metastases are detected. Conventional thoracic imaging for staging and surveillance of STS patients is shown in Figure 1. In the trial, LDCT and MnDCT are added to each imaging visit (Figure 1). A 2-view CXR (CR) is performed (Direct View, Kodak, Rochester) followed by thoracic CT scans performed on a Siemens 16 row MDCT (Sensation 16, Siemens, Erlangen), CT acquisition; 120kVp, 5/2.5/2.5mm. Images are reconstructed with high and low spatial frequency filters and soft copy viewing is performed on a standalone PACS workstation using standard mediastinal (w 350, l 40) and lung (w 1500, l -600) settings. Examinations are performed with varying mAs; SDCT 120 mAs, LDCT 40 mAs and MnDCT 20 mAs. The examinations are evaluated, blinded to the results of the alternative and previous studies, for the presence of nodules (defined as a non-calcified focal opacity ≥3 mm < 3 cm). Surveillance imaging is commenced 3 months post surgery.

• Study Type: Interventional
• Enrollment: 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• High Grade Soft tissue sarcoma

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Detection of metastases

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Narinder Paul, FCPC C, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Study Completion: January 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): April 23, 2007
• Last Update Submitted That Met QC Criteria: April 20, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: 03-0468-CE