NCT04957030

Brief Summary

Therefore, the purpose of this study was to investigate whether ULDCT with ASiR-V can be used for the detection and diameter measurement of pulmonary nodules at an extremely low dose comparable to those associated with plain-film chest radiography. Furthermore, mixed-effects logistic regression analysis was used to determine independent predictors for the sensitivity of pulmonary nodule detection to explore the application range of ULDCT in Chinese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
Last Updated

July 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1 day

First QC Date

June 28, 2021

Last Update Submit

July 4, 2021

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • types of pulmonary nodules

    Two docotrs read images and do this opperation

    through study completion, an average of one month

Secondary Outcomes (1)

  • diameter of pulmonary nodules

    through study completion, an average of one month

Study Arms (2)

ULDCT group

EXPERIMENTAL

underwent ultralow-dose chest CT(ULDCT)

Diagnostic Test: ULDCT group

LDCT group

NO INTERVENTION

underwent conventional chest CT(LDCT)

Interventions

ULDCT groupDIAGNOSTIC_TEST

underwent ultralow-dose chest CT

ULDCT group

Eligibility Criteria

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

You may qualify if:

  • age \> 18 years and BMI ≤ 30 kg/m2
  • fewer than four pulmonary nodules without calcification
  • solid nodules (SNs) with a diameter of 4\~15 mm and subsolid nodules (SSNs) with a diameter of 5\~20 mm and containing part-solid nodules (PSNs) and ground-glass nodules (GGNs) (the diameter is the mean of the longest diameter and perpendicular diameter of a nodule)
  • acceptable diagnostic image quality of LDCT.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • JIE QIAO

    CHAIR

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 9, 2021

Study Start

September 1, 2017

Primary Completion

September 2, 2017

Study Completion

December 14, 2018

Last Updated

July 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)