뇌MRI를 대리결론변수로 하는 임상시험을 위한 병변의 뇌표준판 등록 및 정량분석 소프트웨어 개발: 예비보고 (Development of a Semi-automatic Computer System to Register MRI Lesions Onto a Brain Template for Quantitative Analyses in Clinical Trials Having MRI Findings as Surrogate Endpoints: A Preliminary Rep)

서지정보

· 발행기관 : 대한신경과학회
· 수록지 정보 : 대한신경과학회지 / 27권 / 4호 / 369 ~ 374페이지
· 저자명 : 김동억, 권건한, 고은아, 정지원, 강동희, 탁윤오, 박경종, 정상욱, 최흥국, 지명구, 노상미, 김태윤

초록

Background: Clinical trials that utilize imaging findings as surrogate endpoints are considered to be cost-effective.
However, unlike numeric data, magnetic resonance imaging (MRI) findings are not quantifiable. Thus, we have begun to
develop a software package that is able to convert qualitative MRI findings into quantifiable data.
Methods: Computer software (DUIH_Image) was created with which every patient’s MRI data can be registered on a
standard brain template. Interuser and intrauser reliabilities for the registration were measured, and then a
proof-of-principle experiment was conducted to determine whether the system could identify factors that were
associated with a greater National Institutes of Health Stroke Scale (NIHSS) score at admission. We studied 40
consecutive patients [65.1±14.2 years old (mean±SD); 22 males and 18 females] with first-ever acute lacunar infarction of
the corona radiata, who were divided into two groups according to their NIHSS score (i.e., low: 0–2; high: ≥3). The
following parameters were compared between these two groups: (1) data retrieved from clinical profiles, including
demographic and risk factor variables; and (2) accumulated diffusion MRI lesions mapped on a standard template.
Results: Modest levels of interuser and intrauser reliability were observed (p<0.05, R2=0.63–0.84, Pearson correlations).
Regarding the clinical profiles, no significant difference was found for the numeric data sets or infarct size between the
two groups. However, on the accumulated lesion map image, the lesion area that overlapped the most was located more
posterolaterally in the high NIHSS score group than in the low NIHSS score group.
Conclusions: In this pilot study we have demonstrated the potential usefulness of the DUIH_Image software. We plan to
update this software to enable its utilization in actual clinical trials.

영어초록

Background: Clinical trials that utilize imaging findings as surrogate endpoints are considered to be cost-effective.
However, unlike numeric data, magnetic resonance imaging (MRI) findings are not quantifiable. Thus, we have begun to
develop a software package that is able to convert qualitative MRI findings into quantifiable data.
Methods: Computer software (DUIH_Image) was created with which every patient’s MRI data can be registered on a
standard brain template. Interuser and intrauser reliabilities for the registration were measured, and then a
proof-of-principle experiment was conducted to determine whether the system could identify factors that were
associated with a greater National Institutes of Health Stroke Scale (NIHSS) score at admission. We studied 40
consecutive patients [65.1±14.2 years old (mean±SD); 22 males and 18 females] with first-ever acute lacunar infarction of
the corona radiata, who were divided into two groups according to their NIHSS score (i.e., low: 0–2; high: ≥3). The
following parameters were compared between these two groups: (1) data retrieved from clinical profiles, including
demographic and risk factor variables; and (2) accumulated diffusion MRI lesions mapped on a standard template.
Results: Modest levels of interuser and intrauser reliability were observed (p<0.05, R2=0.63–0.84, Pearson correlations).
Regarding the clinical profiles, no significant difference was found for the numeric data sets or infarct size between the
two groups. However, on the accumulated lesion map image, the lesion area that overlapped the most was located more
posterolaterally in the high NIHSS score group than in the low NIHSS score group.
Conclusions: In this pilot study we have demonstrated the potential usefulness of the DUIH_Image software. We plan to
update this software to enable its utilization in actual clinical trials.

참고자료

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