自动化骨扫描指数的分析验证：作为一种成像生物标志物，用于标准化转移性前列腺癌患者骨扫描的定量变化。

Analytic Validation of the Automated Bone Scan Index as an Imaging Biomarker to Standardize Quantitative Changes in Bone Scans of Patients with Metastatic Prostate Cancer.

机构信息

Department of Translational Medicine, Division of Urological Cancer, Lund University, Malmö, Sweden Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

出版信息

J Nucl Med. 2016 Jan;57(1):41-5. doi: 10.2967/jnumed.115.160085. Epub 2015 Aug 27.

DOI:10.2967/jnumed.115.160085

PMID:26315832

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4975929/

Abstract

UNLABELLED

A reproducible and quantitative imaging biomarker is needed to standardize the evaluation of changes in bone scans of prostate cancer patients with skeletal metastasis. We performed a series of analytic validation studies to evaluate the performance of the automated bone scan index (BSI) as an imaging biomarker in patients with metastatic prostate cancer.

METHODS

Three separate analytic studies were performed to evaluate the accuracy, precision, and reproducibility of the automated BSI. Simulation study: bone scan simulations with predefined tumor burdens were created to assess accuracy and precision. Fifty bone scans were simulated with a tumor burden ranging from low to high disease confluence (0.10-13.0 BSI). A second group of 50 scans was divided into 5 subgroups, each containing 10 simulated bone scans, corresponding to BSI values of 0.5, 1.0, 3.0, 5.0, and 10.0. Repeat bone scan study: to assess the reproducibility in a routine clinical setting, 2 repeat bone scans were obtained from metastatic prostate cancer patients after a single 600-MBq (99m)Tc-methylene diphosphonate injection. Follow-up bone scan study: 2 follow-up bone scans of metastatic prostate cancer patients were analyzed to determine the interobserver variability between the automated BSIs and the visual interpretations in assessing changes. The automated BSI was generated using the upgraded EXINI bone(BSI) software (version 2). The results were evaluated using linear regression, Pearson correlation, Cohen κ measurement, coefficient of variation, and SD.

RESULTS

Linearity of the automated BSI interpretations in the range of 0.10-13.0 was confirmed, and Pearson correlation was observed at 0.995 (n = 50; 95% confidence interval, 0.99-0.99; P < 0.0001). The mean coefficient of variation was less than 20%. The mean BSI difference between the 2 repeat bone scans of 35 patients was 0.05 (SD = 0.15), with an upper confidence limit of 0.30. The interobserver agreement in the automated BSI interpretations was more consistent (κ = 0.96, P < 0.0001) than the qualitative visual assessment of the changes (κ = 0.70, P < 0.0001) was in the bone scans of 173 patients.

CONCLUSION

The automated BSI provides a consistent imaging biomarker capable of standardizing quantitative changes in the bone scans of patients with metastatic prostate cancer.

摘要

未加标签

需要一种可重复和定量的成像生物标志物来标准化有骨骼转移的前列腺癌患者骨扫描变化的评估。我们进行了一系列分析验证研究，以评估自动化骨扫描指数（BSI）作为转移性前列腺癌患者成像生物标志物的性能。

方法

进行了三项独立的分析研究，以评估自动 BSI 的准确性、精密度和可重复性。模拟研究：使用预设肿瘤负担创建骨扫描模拟，以评估准确性和精密度。用低至高疾病融合度（0.10-13.0 BSI）模拟了 50 个骨扫描。第二组 50 个扫描分为 5 个子组，每个子组包含 10 个模拟骨扫描，对应于 0.5、1.0、3.0、5.0 和 10.0 的 BSI 值。重复骨扫描研究：为了在常规临床环境中评估可重复性，在单次 600-MBq（99m）Tc-亚甲基二膦酸盐注射后，从转移性前列腺癌患者中获得了 2 次重复骨扫描。随访骨扫描研究：分析了 2 例转移性前列腺癌患者的 2 次随访骨扫描，以确定自动 BSIs 与视觉评估之间在评估变化时的观察者间变异性。使用升级后的 EXINI 骨（BSI）软件（版本 2）生成自动 BSI。使用线性回归、皮尔逊相关、科恩 κ 测量、变异系数和 SD 评估结果。

结果

证实了自动 BSI 解释在 0.10-13.0 范围内的线性，观察到 Pearson 相关性为 0.995（n=50；95%置信区间，0.99-0.99；P<0.0001）。平均变异系数小于 20%。35 例患者的 2 次重复骨扫描的平均 BSI 差值为 0.05（SD=0.15），置信上限为 0.30。173 例患者的骨扫描中，自动 BSI 解释的观察者间一致性更一致（κ=0.96，P<0.0001），而变化的定性视觉评估的一致性较差（κ=0.70，P<0.0001）。