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

NCT05813808 | Completed

• 1 other identifier: RADPOS1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma,Soft Tissue

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

chest x-ray and ultra-low-dose computed tomography

EXPERIMENTAL

Diagnostic Test: ultra-low-dose computed tomography

Interventions

ultra-low-dose computed tomography DIAGNOSTIC_TEST

7 ultra-low-dose computed tomography imaging

chest x-ray and ultra-low-dose computed tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary high grade soft tissue sarcoma with no metastases at diagnoses or during treatment and treatment with curative intent.

You may not qualify if:

• metastases at diagnoses or during treatment

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Finnish Cancer Society: collaborator

Study Sites (1)

Helsinki University Hospital Comprehensive Cancer Center

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

Location

Related Publications (8)

• 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.

  PMID: 23048062 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.

  PMID: 31134646 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.

  PMID: 33144410 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.

  PMID: 18046031 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.

  PMID: 23344517 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.

  PMID: 29724675 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.

  PMID: 24249538 BACKGROUND

• 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.

  PMID: 38531939 DERIVED

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Mika Sampo, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 14, 2023
• Study Start: June 1, 2017
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)