Clinical trial NCT05813808: Low-dose Computer Tomography in Follow-up of Soft Tissue Sarcomas
Official title: Low-dose Computer Tomography in Follow-up of High Grade Soft Tissue Sarcomas - a Prospective, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma,Soft Tissue
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Finnish Cancer Society
First posted: 2023-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule
timeFrame: 2 years
measure: Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule
timeFrame: 2 years
measure: Number of patients with pulmonary relapse by symptoms
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital Comprehensive Cancer Center
state: Valitse Alue, Osavaltio Tai Maakunta
Study officials:
affiliation: Helsinki University Central Hospital
name: Mika Sampo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.