Study of Low Dose CT in Sarcoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Soft Tissue Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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low dose CT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* High Grade Soft tissue sarcoma

Exclusion Criteria

* None

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Narinder Paul, FCPC C

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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03-0468-CE

Identifier Type: -

Identifier Source: org_study_id