NCT06360627

Brief Summary

Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress67%
Feb 2023Dec 2027

Study Start

First participant enrolled

February 20, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

February 27, 2023

Last Update Submit

April 9, 2024

Conditions

Radiation ExposureLung EmbolismLung CancerPneumonia

Outcome Measures

Primary Outcomes (2)

  • Dose Reduction by new scanner

    mSv per exam will be recorded. This value will be put in correlation to weight (Kg), height (cm) and BMI.

    through study completion, an average of 1 year

  • stable Image Quality in reduced dose scans

    Recorded values compared in 2 populations-different contrast agents by using qualitative\&quantitative methods Qualitative:diagnostic certainty, assessability of lung structure/lesions,diagnostic reliability, Quantitative:Assessment of tissue composition,diagnostic performance measurements Attenuation/sealing measurement (HU), signal-to-noise ratio (SNR), contrast-to-noise ratio ,size dimensions of lung structure/lesion in three dimensions in millimeters Tissue composition assessment diagnostic performance measurements (sensitivity, specificity, accuracy) diagnostic confidence: 1-4 Theses measurements will be put in correlation to the scan dose (mSv) per patient, forming two groups with matched BMI (kg/m\^2)

    through study completion, an average of 1 year

Study Arms (2)

Low Dose

OTHER

Standard Low Dose CT

Radiation: Computed Tomography

Ultra Low Dose

OTHER

Ultra Low Dose CT

Radiation: Computed Tomography

Interventions

Computed TomographyRADIATION

Computed Tomography CHEST

Low DoseUltra Low Dose

Eligibility Criteria

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

You may qualify if:

  • CT SCAN for pulmonary nodule detection/follow up
  • CT SCAN for pneumonia detection/follow up

You may not qualify if:

  • under 18
  • BMI over 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich - Diagnostic Radiology

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Pulmonary EmbolismLung NeoplasmsPneumonia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract InfectionsInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

April 11, 2024

Study Start

February 20, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)