NCT02468609

Brief Summary

To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

January 30, 2015

Last Update Submit

January 26, 2016

Conditions

Multiple Pulmonary NodulesPulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

  • Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT

    Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test

    Participants CT-scan will be read out on an average date of 6 weeks after the scan

Secondary Outcomes (2)

  • Patients BMI (Body mass index)

    Measures assessed at time of read-out on an average date of 6 weeks after the scan

  • Patients Nodule size (mm)

    Measures assessed at time of read-out on an average date of 6 weeks after the scan

Study Arms (1)

Ultralow-Dose-CT

OTHER

Additional Ultralow-Dose-CT of the chest

Radiation: Ultralow-Dose-CT

Interventions

Ultralow-Dose-CTRADIATION

Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT

Ultralow-Dose-CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • planned normal dose-CT by clinical indication at our institution
  • obtained informed consent

You may not qualify if:

  • planned lowdose-CT by clinical indication at institution
  • no informed consent obtained
  • age \< 18 years
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Radiologie und Nuklearmedizin

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Pulmonary NodulesPulmonary Emphysema

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPulmonary Disease, Chronic ObstructiveLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Michael A Messerli, MD

CONTACT

0041 71 494 66 66Michael.Messerli@kssg.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 30, 2015

First Posted

June 11, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

CH(1)