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Study of Low Dose CT in Sarcoma Patients

Primary Purpose

Soft Tissue Sarcoma

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
low dose CT
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Soft Tissue Sarcoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: High Grade Soft tissue sarcoma Exclusion Criteria: None

Sites / Locations

  • Mount Sinai Hospital

Outcomes

Primary Outcome Measures

Detection of metastases

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
April 20, 2007
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00188422
Brief Title
Study of Low Dose CT in Sarcoma Patients
Official Title
Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
low dose CT
Primary Outcome Measure Information:
Title
Detection of metastases

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High Grade Soft tissue sarcoma Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narinder Paul, FCPC C
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Study of Low Dose CT in Sarcoma Patients

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