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| Name | Class |
|---|---|
| Finnish Cancer Society | UNKNOWN |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chest x-ray and ultra-low-dose computed tomography | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultra-low-dose computed tomography | Diagnostic Test | 7 ultra-low-dose computed tomography imaging |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mika Sampo, MD PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital Comprehensive Cancer Center | Helsinki | Valitse Alue, Osavaltio Tai Maakunta | 00290 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23048062 | Background | Treasure T, Fiorentino F, Scarci M, Moller H, Utley M. Pulmonary metastasectomy for sarcoma: a systematic review of reported outcomes in the context of Thames Cancer Registry data. BMJ Open. 2012 Oct 8;2(5):e001736. doi: 10.1136/bmjopen-2012-001736. Print 2012. | |
| 31134646 | Background | Nevala R, Jaamaa S, Tukiainen E, Tarkkanen M, Rasanen J, Blomqvist C, Sampo M. Long-term results of surgical resection of lung metastases from soft tissue sarcoma: A single center experience. J Surg Oncol. 2019 Aug;120(2):168-175. doi: 10.1002/jso.25504. Epub 2019 May 27. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 33144410 | Background | Dammerer D, VAN Beeck A, Schneeweiss V, Schwabegger A. Follow-up Strategies for Primary Extremity Soft-tissue Sarcoma in Adults: A Systematic Review of the Published Literature. In Vivo. 2020 Nov-Dec;34(6):3057-3068. doi: 10.21873/invivo.12140. |
| 18046031 | Background | Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available. |
| 23344517 | Background | Katsura M, Matsuda I, Akahane M, Yasaka K, Hanaoka S, Akai H, Sato J, Kunimatsu A, Ohtomo K. Model-based iterative reconstruction technique for ultralow-dose chest CT: comparison of pulmonary nodule detectability with the adaptive statistical iterative reconstruction technique. Invest Radiol. 2013 Apr;48(4):206-12. doi: 10.1097/RLI.0b013e31827efc3a. |
| 29724675 | Background | Kaasalainen T, Makela T, Kelaranta A, Kortesniemi M. The Use of Model-based Iterative Reconstruction to Optimize Chest CT Examinations for Diagnosing Lung Metastases in Patients with Sarcoma: A Phantom Study. Acad Radiol. 2019 Jan;26(1):50-61. doi: 10.1016/j.acra.2018.03.028. Epub 2018 Apr 30. |
| 24249538 | Background | Puri A, Gulia A, Hawaldar R, Ranganathan P, Badwe RA. Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Clin Orthop Relat Res. 2014 May;472(5):1568-75. doi: 10.1007/s11999-013-3385-9. Epub 2013 Nov 19. |
| 38531939 | Derived | Salminen S, Jaamaa S, Nevala R, Sormaala MJ, Koivikko M, Tukiainen E, Repo J, Blomqvist C, Sampo M. Ultra-low-dose computed tomography and chest X-ray in follow-up of high-grade soft tissue sarcoma-a prospective comparative study. Sci Rep. 2024 Mar 26;14(1):7181. doi: 10.1038/s41598-024-57770-z. |