Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers (QIBs) to measure changes in these features. Critical to the performance of a QIB in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method and metrics used to assess a QIB for clinical use. It is therefore, difficult or not possible to integrate results from different studies or to use reported results to design studies. The Radiological Society of North America (RSNA) and the Quantitative Imaging Biomarker Alliance (QIBA) with technical, radiological and statistical experts developed a set of technical performance analysis methods, metrics and study designs that provide terminology, metrics and methods consistent with widely accepted metrological standards. This document provides a consistent framework for the conduct and evaluation of QIB performance studies so that results from multiple studies can be compared, contrasted or combined.
A prospective study of the Doppler color flow features of 55 proved breast cancers was performed. On a three-level scale of low to marked vascularity, visual assessment of the color flow images classified 82% of the cancers as moderately or markedly vascular (minimal: 14%, moderate: 29%, marked: 53%). Four percent of the cancers had no detectable flow. In 29 women, a volume of tissue comparable to the cancer was scanned in the contralateral normal breast. Sixty-nine percent of the normal breasts had moderate or marked vascularity (minimal: 28%, moderate: 41%, marked: 28%), and 3% were avascular. There was poor distinction between normal tissues and cancer which suggests that more sensitive Doppler methods than were employed in this study may be needed in order to detect the small vessel flow reported to be rather specific for malignancy. The high, 82%, detection rate of tumor vessels in this study suggests the potential use of color flow Doppler for directing more specific but lengthy Doppler procedures.
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