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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813808
Enrollment
50
Registered
2023-04-14
Start date
2017-06-01
Completion date
2023-01-15
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma,Soft Tissue

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTultra-low-dose computed tomography

7 ultra-low-dose computed tomography imaging

Sponsors

Finnish Cancer Society
CollaboratorUNKNOWN
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule2 years
Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule2 years
Number of patients with pulmonary relapse by symptoms2 yearsPulmonary relapse based on patient-reported symptoms leading to positive finding in x-ray and or conventional chest CT between two control imaging rounds.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026