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Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma


Phase 1
16 Years
N/A
Not Enrolling
Both
Soft Tissue Sarcoma

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Trial Information

Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma


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.


Inclusion Criteria:



- High Grade Soft tissue sarcoma

Exclusion Criteria:

- None

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Detection of metastases

Principal Investigator

Narinder Paul, FCPC C

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Health Canada

Study ID:

03-0468-CE

NCT ID:

NCT00188422

Start Date:

August 2003

Completion Date:

January 2006

Related Keywords:

  • Soft Tissue Sarcoma
  • Sarcoma

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