Trial Outcomes & Findings for FDG-PET Imaging in Young Cystic Fibrosis Patients (NCT NCT00846053)

Results Overview

The whole lung kinetic influx constant (Ki) is the primary outcome measure that is derived from the time-activity curves, which are generated from regions of interest placed over the whole lungs. Therefore, a single time-activity curves from each scan is used to derive the Ki.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

At the time of FDG scan, 1 to 2 hours

Results posted on

2018-07-24

Participant Flow

January 2009-December 2012, St. Louis Children's Hospital Cystic Fibrosis Clinics (St. Louis)

Participant milestones

Participant milestones
Measure	Stable Lung Function Group S will consist of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.	Rapidly Decline Lung Function Group R will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline.
Overall Study STARTED	13	8
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stable Lung Function Group S will consist of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.	Rapidly Decline Lung Function Group R will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline.
Overall Study Physician Decision	3	0

Baseline Characteristics

FDG-PET Imaging in Young Cystic Fibrosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stable Lung Function n=10 Participants Group S (n = 14) will consist of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.	Rapidly Declining Lung Function n=8 Participants Group R (n = 14) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline, as defined in our previous study.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15 years STANDARD_DEVIATION 1.9 • n=5 Participants	16.6 years STANDARD_DEVIATION 2.9 • n=7 Participants	15.5 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of FDG scan, 1 to 2 hours

Population: CF adolescents and young adults, ages 12 to 21 years, who did not have CFRD.

The whole lung kinetic influx constant (Ki) is the primary outcome measure that is derived from the time-activity curves, which are generated from regions of interest placed over the whole lungs. Therefore, a single time-activity curves from each scan is used to derive the Ki.

Outcome measures

Outcome measures
Measure	Stable Lung Function n=10 Participants Group S (n = 10) consisted of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.	Rapidly Declining Lung Function n=8 Participants Group R (n = 8) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years
Kinetic Influx Constant (Ki)	0.009 mL/min/mL Standard Deviation 0.008	0.013 mL/min/mL Standard Deviation 0.008

SECONDARY outcome

Timeframe: Sample collected within 2-hours of PET scan

Population: Not every participant in the stable lung function group could produce sputum.

Using established techniques, functional activity of neutrophil elastase in sputum sols were measured using methoxy-succinyl-ala-ala-pro-val-nitroanilide (Elastin Products, Owensville, MO), specific peptide chromogenic substrates of the neutrophil protease

Outcome measures

Outcome measures
Measure	Stable Lung Function n=7 Participants Group S (n = 10) consisted of CF patients, aged 12-21 years old, with stable lung function during the past 4 years, defined as less than 2% decline per year.	Rapidly Declining Lung Function n=8 Participants Group R (n = 8) will contain CF patients, aged 12-21 years old, with rapidly deteriorating lung function during the past 4 years
Sputum Neutrophil Elastase (NE) Concentration	2179 microgram (mcg) NE /mcg protein Standard Deviation 2046	1656 microgram (mcg) NE /mcg protein Standard Deviation 926

Adverse Events

Stable Lung Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapidly Declining Lung Function

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

Thomas Ferkol, MD

Washington University

Phone: 314 454 6000

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place