Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188422
Status:
COMPLETED
Last Update Posted:
2007-04-23
First Post:
2005-09-12
Brief Title:
Study of Low Dose CT in Sarcoma Patients
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 52525mm 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None