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

Sarcoma,Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05813808
• Other study ID #: RADPOS1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma,Soft Tissue

Intervention

Diagnostic Test:
• ultra-low-dose computed tomography
7 ultra-low-dose computed tomography imaging

Locations

Country	Name	City	State
Finland	Helsinki University Hospital Comprehensive Cancer Center	Helsinki	Valitse Alue, Osavaltio Tai Maakunta

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finnish Cancer Society

Country where clinical trial is conducted

Finland, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule		2 years
Primary	Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule		2 years
Primary	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