Clinical trials in oncology demand standardized measurements of imaging scans to assess treatment response, but, unfortunately, the existing clinical workflow is not designed to produce these cohesive measurements on a routine basis. A group from Dana Farber Cancer Center has proposed using imaging analysts to deliver more consistent results.
Clinical trials in oncology demand standardized measurements of imaging scans to assess treatment response, but, unfortunately, the existing clinical workflow is not designed to produce these cohesive measurements on a routine basis. A group from Dana Farber Cancer Center has proposed using imaging analysts to deliver more consistent results.
Some of the issues that currently plague imaging assessment for clinical trials include different readers across different timepoints and inconsistent measurements between clinical radiology platforms, said Trinity Urban and colleagues in their RSNA educational exhibit.
They have devised a centralized imaging metrics core that is managed by a team of trained imaging analysts (IA). These analysts serve as a point of contact between trial staff and radiologist reviewers. An IA will assess images and assign Response Evaluation Criteria In Solid Tumors (RECIST) measurements before the final read by a radiologist.
Urban's group enlisted four multimodality-trained IAs to select and measure the longest diameter of 186 lesions from 20 CT scans. Disease states included breast, lung, and gynecological cancers. The results showed high agreement between measurements rendered by the four IAs (95% confidence interval). Only 5.4% of the measurements required revision following review by a radiologist. Overall, radiologist assessment time was reduced by about 30%.
"Utilizing multimodality IAs improved the quality for radiological assessment of tumor measurements and improved the use of imaging modalities as predictive and prognostic biomarkers in clinical research," Urban's group said.
Some of the requirements of an IA include anatomical knowledge in cross-sectional imaging and familiarity with Health Insurance Portability and Accountability Act regulations as well as with the guidelines from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Additional information on the metrics core program can be found on the group's website.
Maintaining imaging continuity will be particularly important after the National Cancer Institute introduces new RECIST guidelines in early 2009. Changes to RECIST will include additional measurements such as tumor burden and lymph nodes. The definition for nonmeasurable diseases will be expanded as well. The new guidelines are slated for publication in the European Journal of Cancer.
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