Trial Outcomes & Findings for Assessment of Lung Movement With Computed Tomography (CT) (NCT NCT03068091)

NCT ID: NCT03068091

Last Updated: 2020-05-01

Results Overview

A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Study visit 1 of a single visit study

Results posted on

2020-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Pulmonary Assessment All participants will undergo a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Lung Movement With Computed Tomography (CT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulmonary Assessment n=24 Participants All participants will undergo a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Study visit 1 of a single visit study

Population: A total of 9 IPF subjects and 13 control subject had CT scans that could be analyzed.

A computer algorithm will compare the inspiration and expiration CT scans to determine regional lung motion.

Outcome measures

Outcome measures
Measure	Pulmonary Assessment n=22 Participants All participants underwent a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function
Lung Motion as Assessed by CT Lung Volume Inspiration, IPF	4.07 Liters Standard Deviation 0.98
Lung Motion as Assessed by CT Lung Volume Inspiration, Control	5.56 Liters Standard Deviation 0.9
Lung Motion as Assessed by CT Lung Volume Expiration, IPF	1.82 Liters Standard Deviation 0.30
Lung Motion as Assessed by CT Lung Volume Expiration, Control	2.46 Liters Standard Deviation 0.56

SECONDARY outcome

Timeframe: Study visit 1 of a single visit study

Population: 9 idiopathic pulmonary fibrosis (IPF) and 13 control subjects (N=22) had CT's that were able to be analyzed for lobar strain (lung motion).

Lobar strain (S): the volumetric strain of each lobe i \[i = Right Upper (RU), Right Lower (RL), Left Lower (LL), and Left Upper (LU)\] as the difference in lobe volume between the expanded and contracted states, normalized by the lobe volume in the expanded state

Outcome measures

Outcome measures
Measure	Pulmonary Assessment n=22 Participants All participants underwent a Chest CT scan and pulmonary function testing Chest CT: Inspiration and expiration chest CT Pulmonary Function Testing: Measure lung function
Lung Motion: Lobar Strain Which is a Ratio IPF	0.37 Ratio Standard Deviation 0.15
Lung Motion: Lobar Strain Which is a Ratio Control	0.39 Ratio Standard Deviation 0.30

Adverse Events

Pulmonary Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Talissa Altes

University of Missouri

Phone: 573 882 1026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place