Radiology workflow for RECIST assessment in clinical trials: Can we reconcile time-efficiency and quality?

PURPOSE: In oncology clinical trials, nonconformity issues are frequently reported. Radiological workload is increasing, thus reducing radiologists' availability and affecting diagnostic quality. We compared performances of a standard radiological workflow (SW) and a novel "hybrid workflow" (HW). METHOD: We prospectively studied imaging data of 40 patients included in RECIST 1.1 clinical trials. Ninety-six time-points were reviewed by 7 radiologists and one trained technologist. Nonconformities using the SW were retrieved from hospital archives. For the HW, radiologists performed all baseline evaluations; the technologist made subsequent measurements. Finally, the radiologists checked the technologist's findings before confirming the evaluations. The HW enabled implementation of an electronic reporting system. An independent body compared SW and HW reading times and nonconformity occurrences. RESULTS: Using SW, 19 types of nonconformity were found: blank report (13%); unsigned report (11%); undocumented change of tumor burden (10%); undocumented new lesions (9%); missing/wrong patients' appointment dates (7%); undocumented tumor location (5%); error in tumor burden change (5%). SW and HW nonconformities affected 55% (179/323) and 5% (2/40) of reports, respectively (p < 0.001). HW nonconformities were: one inaccurate login name was used on the platform, and one erroneous time-point number. On average, SW required 11'30″ [10'06″; 13'20″] per time-point. HW required 1'35″ [40″; 5'08″] for radiologists, and 12'18″ [11'12″; 14'18″] for the technologist. CONCLUSIONS: HW significantly reduced the number of trial nonconformities and saved 87% of radiologists' time while enabling them to apply their expertise to final decisions. HW could offer an effective opportunity for cost reduction associated with improved imaging trial quality.

Magnetic resonance imaging for secondary assessment of breast density in a high-risk cohort.

A quantitative measure of three-dimensional breast density derived from noncontrast magnetic resonance imaging (MRI) was investigated in 35 women at high-risk for breast cancer. A semiautomatic segmentation tool was used to quantify the total volume of the breast and to separate volumes of fibroglandular and adipose tissue in noncontrast MRI data. The MRI density measure was defined as the ratio of breast fibroglandular volume over total volume of the breast. The overall correlation between MRI and mammographic density measures was R(2)=.67. However the MRI/mammography density correlation was higher in patients with lower breast density (R(2)=.73) than in patients with higher breast density (R(2)=.26). Women with mammographic density higher than 25% exhibited very different magnetic resonance density measures spread over a broad range of values. These results suggest that MRI may provide a volumetric measure more representative of breast composition than mammography, particularly in groups of women with dense breasts. Magnetic resonance imaging density could potentially be quantified and used for a better assessment of breast cancer risk in these populations.