Study of Low Dose CT in Sarcoma Patients
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Purpose
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
- LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).
- MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma |
Procedure: low dose CT |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma |
- Detection of metastases
| Estimated Enrollment: | 70 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- High Grade Soft tissue sarcoma
Exclusion Criteria:
- None
Contacts and Locations| Canada, Ontario | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Narinder Paul, FCPC C | University Health Network, Toronto |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00188422 History of Changes |
| Other Study ID Numbers: | 03-0468-CE |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 20, 2007 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013