New: QIBA Conformance Certification Service for Clinical Sites

Medical scanners and image analysis software systems are now routinely being used to obtain precise quantitative image measurements, which can often play a major role in patient care. It is therefore critical that clinical sites verify that their medical scanning equipment, including image acquisition protocols and analysis software, have been thoroughly evaluated to achieve high levels of performance for specific measurement tasks. Fortunately, the Radiological Society of North America’s (RSNA) Quantitative Imaging Biomarkers Alliance (QIBA) has developed specification documents, called Profiles, that specify the requirements and technical performance needed for quantitative image measurement tasks. In addition, QIBA is now working closely with Accumetra to provide a new QIBA Conformance Certification Service that makes it easy for any clinical site to quickly verify conformance with a QIBA Profile and receive a QIBA Conformance Certification Mark that can be used to communicate the achievement.

Achieving accurate volume measurements of small (6 to 10 mm diameter) solid lung nodules is critical to determining the malignancy potential of suspicious lung nodules that are identified in the standard care setting as well as in CT lung cancer screening. Although it may appear that current CT scanners are more than capable of reliably performing these quantitative measurements with high quality due to their ability to obtain sub-millimeter resolution lung images, many clinical sites are not taking the steps needed to achieve consistent high quality small lung nodule measurement results. A study of volume measurement performance in a phase II clinical trial observed multiple clinical sites using CT scanners which resulted in errors in volume change measurements as high as 43% [1]. In addition, a 2016 crowd-sourcing study of CT scanner image quality performance using a site’s low dose CT lung cancer screening acquisition protocol revealed that 37% of sites used insufficient slice thickness (<= 1.25mm slice thickness is needed) and only 19% of sites used the needed slice thickness and a reconstruction kernel that avoided excessive smoothing and avoided high levels of edge enhancement [2]. Poor CT image acquisition performance has the potential to result in high variability in lung nodule volume measurement performance, which can negatively impact patient care by contributing to unnecessary biopsies and delays in early lung cancer diagnosis.

To address these issues the RSNA’s Quantitative Imaging Biomarkers Alliance (QIBA®) has developed the QIBA CT Small Lung Nodule Profile along with a new QIBA Conformance Certification Service. The Profile provides a comprehensive set of specifications to ensure that a clinical site attains a minimum level of quantitative imaging performance necessary to achieve a specified lung nodule volume measurement accuracy.

The QIBA Conformance Certification Service for the CT Small Lung Nodule Profile provides guidance to sites on steps needed to achieve high quality lung nodule measurements and provides easy to use tools and resources to verify that a CT scanner, CT image acquisition protocol, and analysis software have the necessary performance to achieve high quality results. To be able to verify that a CT scanner and saved CT image acquisition protocol are conformant with the technical specifications in the QIBA Small Lung Nodule Profile, a site is provided with a CTLX1 phantom and is given access to upload phantom scans to Accumetra’s phantom analysis service and receive back automated and easy to read phantom analysis reports. Clinical sites are also expected to test the performance of their nodule volume analysis software on clinical zero change CT datasets and synthetic nodule CT scan datasets.

To use this service and obtain an institution-specific QIBA Conformance Certification Mark, a clinical site must register and pay $1,950 + tax for three years of conformance certification services for each CT scanner that is being used for small lung nodule measurements. In addition, the clinical site is recommended to purchase one CTLX1 phantom for each co-located group of CT scanners that will be under a QIBA Conformance Certification Service contract. The cost of one CTLX1 phantom is $390 + shipping and tax.

Benefits of obtaining a QIBA® Conformance Certification Mark for a Clinical Site:

• Confirm that your clinical site is delivering high quality CT lung nodule imaging measurements to patients.
• Quantitatively identify, optimize and monitor any potential CT image quality performance issues.
• Obtain high-quality measurements based on fundamental CT image quality characteristics and lung imaging protocols which can be useful when conducting clinical trials and algorithmic imaging research.
• Promote your high-performance, quantitative imaging capability by posting the QIBA® Conformance Certification Mark to your website and imaging site materials.
• Participation will help improve future CT lung cancer imaging guidelines.

For more information, see the QIBA Conformance Certification Service Frequently Asked Questions (FAQ). Register References [1] Henschke CI, Yankelevitz DF, Yip R, Archer A, Zahlmann G, Krishnan K, Helba B, Avila R, “Tumor volume measurement error using computed tomography imaging in a phase II clinical trial in lung cancer.” Journal of Medical Imaging 3(3), 035505 (Jul–Sep 2016). [2] Avila R, Yankelevitz D, Yip R, Henschke C, “P1.03-021 Initial Results from A Novel and Low Cost Method For Measuring CT Image Quality,” January 2017. Journal of Thoracic Oncology 12(1):S554-S555.