Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases

NCT04119115 | Terminated

• 1 other identifier: 2019-241
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if combining a state-of-the-art form imaging modality with metabolomics in different types of Interstitial Lung Diseases (ILD) patients compared to controls with chronic obstructive pulmonary disorder (COPD)/emphysema and healthy controls will be a better predictor of disease progression. ILD's are a group of chronic, progressive lung diseases. The most common ILD is idiopathic pulmonary fibrosis (IPF). Metabolomics provides a "snapshot" in time of all metabolites present in a biological sample. The imaging procedure should take approximately 20 minutes. All study related collections of samples will be done in a single visit if possible. There are no direct benefits to participants. This is not a treatment study.

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Keywords

lung disease; pulmonary fibrosis; precision medicine; metabolomics

Outcome Measures

Primary Outcomes (2)

• Quantitative image lung function

  CT-V scores between inhalation and exhalation will be calculated at a voxel level on each lung using the "Integrated Jacobian Formulation" (IJV) CT-V method in patients with IPF, non-IPF ILD and COPD/emphysema patients. Several factors, including the volume of identified "cold spots" (areas with decreased ventilation), total ventilation (the integral of CT-V image over the whole lung), and texture analytics (local means, variances, etc.) will be used to define a CT-V pulmonary function metric. This measure is reported in liters with lower numbers indicating reduced lung function.

  baseline

• Forced Vital Capacity baseline

  Maximum volume exhaled in liters measured on a spirometer at baseline

  baseline

Secondary Outcomes (2)

• Untargeted Metabolic profile of breath

  baseline

• Untargeted Metabolic profile of Serum

  baseline

Study Arms (3)

Interstitial Lung Disease (ILD)

CT-V and metabolite analysis of breath and serum at baseline

Device: CT-V; Other: Metabolites

COPD/Emphysema: Age-matched control

CT-V and metabolite analysis of breath and serum at baseline

Device: CT-V; Other: Metabolites

Healthy Volunteers: Age-matched + /- 10 yrs controls

Metabolite analysis of breath and serum at baseline

Other: Metabolites

Interventions

CT-V DEVICE

CT-V is a newer computed tomography scan which is more comprehensive and tracks movement of the lungs.

Also known as: Quantitative lung function imaging and lung compliance imaging

COPD/Emphysema: Age-matched control; Interstitial Lung Disease (ILD)

Metabolites OTHER

Metabolites are compounds which can be measured in biospecimens and may indicate a disease or biological process.

COPD/Emphysema: Age-matched control; Healthy Volunteers: Age-matched + /- 10 yrs controls; Interstitial Lung Disease (ILD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pulmonary outpatient clinic and interstitial lung disease clinic at Beaumont Hospital, Royal Oak

You may qualify if:

• Patients greater than 18 years of age
• Patients with a PFT-Pulmonary function test \</=3 month plus seven days
• Patients with idiopathic pulmonary fibrosis (IPF), or
• Patients with interstitial lung disease (ILD) other than IPF, or
• Patients with chronic obstructive pulmonary disease COPD/emphysema based on Principal's Investigator's assessment/review, or
• Control subject, someone without a diagnosis of above and deemed and "healthy control" by the PI.
• COPD/emphysema and control subjects will be age matched +/-10 years to the ILD subjects.

You may not qualify if:

• Patients less than 18 years of age
• Patients with active malignancy in past one year, except for basal and squamous cell skin cancer
• Patients without a PFT-Pulmonary function test \</=3 month plus seven days
• Pregnant females
• Cognitive impairment and unable to follow directions, per PI discretion

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis; Lung Diseases

Interventions

Phytoalexins

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Toxins, Biological; Biological Factors

Study Officials

• Girish B Nair, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Medicine Physician

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: September 30, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)