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  1. CDRH Research Programs

Dose and Image Quality in Medical Imaging

Contact

Aldo Badano, Ph.D.

Summary

In this program we research new image quality (IQ) evaluation methodologies in response to recent developments in X-ray Computed Tomography (CT) systems including iterative image reconstruction algorithms, enhancements in dual energy CT, and other nonlinear techniques. Devices based on these technologies come with claims of generating images of diagnostic value equal to or better than those obtained by conventional CT. Quantitative dose reduction claims require special testing beyond what standard CT metrics provide. We are developing physical testing methodologies, using task-based paradigms, involving the measurement of the detectability of signals at unknown location. The signal search task is clinically more realistic and more sensitive to changes in noise level and pattern. We developed phantoms for such testing and are experimentally validating and further improving the proposed procedures for 3D applications. The outcomes of this program will facilitate the interpretation of results and the comparison among devices to address specific dose reduction claims, enabling FDA to promptly address regulatory reviews of new generation imaging diagnostic devices.

Example CT image with suspicious signal locations, the true signals (marked with small circles and *), and the regions of interest randomly selected for analysis.

Example CT image with suspicious signal locations, the true signals (marked with small circles and *), and the regions of interest randomly selected for analysis.

Current funding sources

FDA Critical Path Initiative

Personnel

FDA Staff:
Andreu Badal-Soler, Ph.D.
Rongping Zheng, Ph.D.

Research Fellows:
Bahaa Ghammraoui, Ph.D.
Aria Pezeshk, Ph.D.

Resource facilities

Imaging physics laboratory

  • X-ray tubes:
    • Several rotating tungsten anode Varian medical X-ray tubes (RAD-70SP, G-1582BI)
    • X-ray microfocus source from OXFORD Instruments designed for applications where high power, high magnification and small spot size are important.
  • Digital flat-panel energy integrating detectors:

Public Domain Software

A. Wunderlich, IQmodelo: Statistical software for image quality assessment with model observersdisclaimer icon, 2014.
 

Selected peer-review publications