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

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05813808
Collaborator
Finnish Cancer Society (Other)
50
1
1
67.5
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultra-low-dose computed tomography
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Low-dose Computer Tomography in Follow-up of High Grade Soft Tissue Sarcomas - a Prospective, Comparative Study
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Jan 15, 2023
Actual Study Completion Date :
Jan 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: chest x-ray and ultra-low-dose computed tomography

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule [2 years]

  2. Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule [2 years]

  3. Number of patients with pulmonary relapse by symptoms [2 years]

    Pulmonary relapse based on patient-reported symptoms leading to positive finding in x-ray and or conventional chest CT between two control imaging rounds.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Hospital Comprehensive Cancer Center Helsinki Valitse Alue, Osavaltio Tai Maakunta Finland 00290

Sponsors and Collaborators

  • Helsinki University Central Hospital
  • Finnish Cancer Society

Investigators

  • Principal Investigator: Mika Sampo, MD PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mika Sampo, Senior Consultant, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT05813808
Other Study ID Numbers:
  • RADPOS1
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023