NCT04482114

Brief Summary

evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

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

First Submitted

Initial submission to the registry

July 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

July 15, 2020

Last Update Submit

March 21, 2023

Conditions

Pulmonary Nodules, Multiple

Keywords

lung nodulespulmonary noduleslung cancerradiation dosedose reductionlow dose CTultra-low dose CTDLIRdeep learning reconstruction

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    The study aimed to investigate the diagnostic accuracy (Sensibility and Specificity) of ultra-low dose CT using DLIR reconstruction for the detection of pulmonary nodules in comparison with the low dose CT reference protocol.

    Day 0

Secondary Outcomes (2)

  • Image quality

    Day 0

  • Pulmonary nodules volume

    Day 0

Study Arms (1)

ultra-low dose CT

OTHER

All the examinations are part of the routine care. Addition of the ULD CT protocol does not require injection of contrast agent and does not extend the duration of the examination.

Radiation: ULD CT

Interventions

ULD CTRADIATION

All the examinations are part of the routine care. Addition of the ULD CT protocol does not require injection of contrast agent and does not extend the duration of the examination.

ultra-low dose CT

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years old,
  • Patient referred for non-enhanced chest CT for lung nodule check-up or follow-up,
  • Affiliation to a social security program,
  • Ability of the subject to understand and express opposition

You may not qualify if:

  • Age \<18 years old,
  • Person under guardianship or curatorship,
  • Pregnant woman,
  • Any contraindications to CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80000, France

Location

MeSH Terms

Conditions

Multiple Pulmonary NodulesLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective transversal monocentric study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 22, 2020

Study Start

July 22, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

FR(1)