Low-dose Computer Tomography in Follow-up of Soft Tissue Sarcomas

Study Overview
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Brief Summary
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The goal of this interventional study is to compare sensitivity of regular chest x-ray to ultra-low-dose computed tomography to find pulmonary relapse in follow-up of soft tissue sarcoma. The main question[s] it aims to answer are: Is ultra-low-dose computed tomography more sensitive than regular chest x-ray to find pulmonary relapse? Does ultra-low-dose computed tomography detect the most fast-growing pulmonary metastases earlier than regular chest x-ray? Participants will have seven ultra-low-dose computed tomography imagings in addition to simultaneous routine protocol of chest x-rays. Participants therefore work as their own controls.

Detailed Description
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After primary treatment with curative intent for soft tissue sarcoma, patients fulfilling the inclusion criteria and giving informed consent are enrolled. In study protocol patients have their regular chest x-ray once in two months plus ultra-low-dose computed tomography imaging is repeated seven times during the first two years of follow-up. After two years patients without detectable metastases continue in regular follow-up program. The aims of this prospective comparative study are to investigate whether ultra-low-dose computed tomography is more accurate than chest x-ray in soft tissue sarcoma and especially whether the most fast-growing pulmonary metastases could be detected earlier.

Official Title
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Low-dose Computer Tomography in Follow-up of High Grade Soft Tissue Sarcomas - a Prospective, Comparative Study

Conditions
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Sarcoma,Soft Tissue

Intervention / Treatment
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* Diagnostic Test: ultra-low-dose computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary high grade soft tissue sarcoma with no metastases at diagnoses or during treatment and treatment with curative intent. Exclusion Criteria: metastases at diagnoses or during treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chest x-ray and ultra-low-dose computed tomography<br> | Diagnostic Test: ultra-low-dose computed tomography<br>* 7 ultra-low-dose computed tomography imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule |  | 2 years | 
| Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule |  | 2 years | 
| Number of patients with pulmonary relapse by symptoms | Pulmonary relapse based on patient-reported symptoms leading to positive finding in x-ray and or conventional chest CT between two control imaging rounds. | 2 years |