NCT03159377

Brief Summary

We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult patients undergoing a clinically indicated chest CT. Using a recently developed computationally efficient algorithm for the denoising of ULDCT scans after image reconstruction, we will compare the sensitivity, specificity and accuracy of lesion detection with the ULDCT as compared to the regular CT scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

May 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

May 17, 2017

Last Update Submit

October 14, 2021

Conditions

Pulmonary Nodule, Multiple

Keywords

pulmonary nodule, CT, low dose

Outcome Measures

Primary Outcomes (1)

  • Identification of a pulmonary nodule

    Comparison of sensitivity, specificity and accuracy in identifying a pulmonary nodule when comparing denoised ULDCT to a regular CT.

    Patient collection in two years

Study Arms (1)

Patients scheduled for a chest CT

Inpatients or outpatients scheduled for a chest CT in our medical center

Device: Ultra low dose chest CT

Interventions

Ultra low dose chest CTDEVICE

Performing an ultra low dose chest CT (ULDCT) in addition to a clinically indicated chest CT and assessing nodule detection with a recently developed denoising algorithm

Patients scheduled for a chest CT

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any adult patient scheduled for a chest CT, in-patient or outpatient, in our institution

You may qualify if:

  • Any adult patient scheduled for a chest CT, in-patient or outpatient

You may not qualify if:

  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Edith M Marom, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 18, 2017

Study Start

July 4, 2017

Primary Completion

January 31, 2018

Study Completion

July 6, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations

IL(1)