Lung Density Biomarker Ctte

This Wiki is for collaborative creation of QIBA's Chronic Obstructive Pulmonary Disease (COPD) and Asthma Committee materials and ongoing activities.

Mission: Reduce and characterize bias and variance across manufacturers, versions, and sites in support of quantitative CT lung densitometry and morphology.

Initial Objectives:

• Characterize the precision and accuracy of phenotyping and progression measurements in emphysema and asthma.

This is an essential effort to classify phenotype and assess longitudinal changes as medically meaningful surrogates for health status.

• Compare the sensitivity of CT measurements to spirometry and other accepted measures.

This will be necessary in order to determine if Progressive Disease can be detected significantly sooner with quantitative imaging techniques than with currently accepted methods.

Profiling Activities

• COPD QIBA Profile v0.2
• COPD UPICT Protocol v0.2

• Thoughts on the QIBA Process: Profiles, UPICT & Measurements by Kevin O’Donnell-20090629

• Claim Language/Detail

Protocol Development Activities

• UPICT Template

Groundwork Activities

Validate key concepts and answer key questions needed to write the Profiles and demonstrate their effectiveness.

• Phantom project

Meetings / Call Summaries

• COPD Group Call Summaries

Working Documents

• COPD Density Matrix V3

• COPD Morphology Matrix V1

Reference Documents

• Pulmonary Emphysema: Objective Quantification at Multi–Detector Row CT—Comparison with Macroscopic and Microscopic Morphometry Madani et al, Radiology: Volume 238: Number 3-March 2006

• Pulmonary Emphysema: Radiation Dose and Section Thickness at Multidetector CT Quantification—Comparison with Macroscopic and Microscopic Morphometry Madani et al, Radiology: Volume 243: Number 1-April 2007

• COPDGene protocol section
• ECLIPSE protocol description
• ECLIPSE CT protocol specifics
• Coxson's chairman summary
• Hoffman et al's paper on quantitative assessment
• Stoel et al's paper on volume correction
• Stoel et al's paper on longitudinal studies
• FDA Guidance for Industry - Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment