Study of Low Dose CT in Sarcoma Patients
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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Procedure: low dose CT
Outcome Measures for this Clinical Trial
Primary Measures
- Detection of metastases
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- High Grade Soft tissue sarcoma
Exclusion Criteria:
- None
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University Health Network, Toronto Other
Overall Clinical Trial Officials and Contacts
Narinder Paul, FCPC C Principal Investigator University Health Network, Toronto
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00188422
Study ID Number: 03-0468-CE
ClinicalTrials.gov Identifier: NCT00188422
Health Authority: Canada: Health Canada
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00188422
