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NCT Number: NCT05813808

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

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.

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Key information

Conditions

Sarcoma,Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, Valitse Alue, Osavaltio Tai Maakunta, 00290, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultra-low-dose computed tomography

Diagnostic Test

7 ultra-low-dose computed tomography imaging

Primary outcomes

  1. Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule

    Time frame: 2 years

  2. Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule

    Time frame: 2 years

  3. Number of patients with pulmonary relapse by symptoms

    Time frame: 2 years

    Pulmonary relapse based on patient-reported symptoms leading to positive finding in x-ray and or conventional chest CT between two control imaging rounds.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Cancer Society

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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