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

April 14, 2023 updated by: Mika Sampo, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Valitse Alue, Osavaltio Tai Maakunta
      • Helsinki, Valitse Alue, Osavaltio Tai Maakunta, Finland, 00290
        • Helsinki University Hospital Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with pulmonary relapse detected by ultra-low-dose CT performed according to a pre-defined schedule
Time Frame: 2 years
2 years
Number of patients with pulmonary relapse detected by chest x-ray performed according to a pre-defined schedule
Time Frame: 2 years
2 years
Number of patients with pulmonary relapse by symptoms
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Finnish Cancer Society

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADPOS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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