Low-dose Computer Tomography in Follow-up of Soft Tissue Sarcomas
Primary Purpose
Sarcoma,Soft Tissue
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ultra-low-dose computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcoma,Soft Tissue
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
Sites / Locations
- Helsinki University Hospital Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chest x-ray and ultra-low-dose computed tomography
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule
Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05813808
First Posted
March 30, 2023
Last Updated
April 14, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
Finnish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT05813808
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Finnish Cancer Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma,Soft Tissue
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chest x-ray and ultra-low-dose computed tomography
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
ultra-low-dose computed tomography
Intervention Description
7 ultra-low-dose computed tomography imaging
Primary Outcome Measure Information:
Title
Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule
Time Frame
2 years
Title
Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule
Time Frame
2 years
Title
Number of patients with pulmonary relapse by symptoms
Description
Pulmonary relapse based on patient-reported symptoms leading to positive finding in x-ray and or conventional chest CT between two control imaging rounds.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Sampo, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital Comprehensive Cancer Center
City
Helsinki
State/Province
Valitse Alue, Osavaltio Tai Maakunta
ZIP/Postal Code
00290
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23048062
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.
Results Reference
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PubMed Identifier
31134646
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.
Results Reference
background
PubMed Identifier
33144410
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.
Results Reference
background
PubMed Identifier
18046031
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.
Results Reference
background
PubMed Identifier
23344517
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.
Results Reference
background
PubMed Identifier
29724675
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.
Results Reference
background
PubMed Identifier
24249538
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.
Results Reference
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Low-dose Computer Tomography in Follow-up of Soft Tissue Sarcomas
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