MedPath

Study of Low Dose CT in Sarcoma Patients

Phase 1
Completed
Conditions
Soft Tissue Sarcoma
Registration Number
NCT00188422
Lead Sponsor
University Health Network, Toronto
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria
  • High Grade Soft tissue sarcoma
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Exclusion Criteria
  • None
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Detection of metastases
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mount Sinai Hospital

🇨🇦

Toronto, Ontario, Canada

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