The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database.
The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database.
复制标题
作者：
Chen YP;Lv JW;Liu X;Zhang Y;Guo Y;Lin AH;Sun Y;Mao YP;Ma J
在以个性化医学为标志的癌症战争中，正电子发射断层扫描（PET）基于治疗的疗法策略正在发挥越来越重要的作用。精心设计的临床试验对于验证宠物应用和确保循证癌症护理具有重要意义。这项研究旨在使用临床的大量资源来提供宠物临床试验特征的全面景观。gov数据库。我们在最后十年（2005年10月至2015年9月）中确定了在ClinicalTrials.gov上注册的25,599次肿瘤学试验。对他们进行了系统的审查，以验证分类为519个宠物试验和25,080次其他肿瘤学试验。我们发现，使用非随机分配的PET试验主要是1-2期研究（86.2％），更有可能是单臂（78.9％vs. 57.9％，p <0.001）（90.1％vs. 66.7％，，p <0.001） P <0.001）比其他肿瘤学试验。此外，宠物试验的规模很小，通常少于100名参与者（对于其他肿瘤学试验，20.3％比25.7％，p = 0.014），这可能太小了，无法检测出明显的疗法效应。随着时间的推移，行业或国立卫生研究院的资金支持缩减（均下降了约5％），只有一个缺乏国际合作的地区，更有可能进行宠物试验（对于其他肿瘤学试验，97.0％比89.3％ p <0.001）。这些发现引起了人们的关注，即评估肿瘤学中PET成像的临床试验没有得到产生高质量证据所必需的关注或努力。推进宠物成像的临床应用将需要一致的努力来提高试验质量。
In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials.
登录
查看更多内容
中期和治疗后 F-18-FDG PET/CT 扫描对成年伯基特淋巴瘤患者的预后价值
影响因子：
--
作者：
Wei WX;Huang JJ;Li WY;Zhang X;Xia Y;Jiang WQ;Fan W;Li ZM
通讯作者：
Li ZM
影响因子：
5.6
作者：
Jauw YW;Menke-van der Houven van Oordt CW;Hoekstra OS;Hendrikse NH;Vugts DJ;Zijlstra JM;Huisman MC;van Dongen GA
通讯作者：
van Dongen GA
影响因子：
3.7
作者：
Kakkis ED;O'Donovan M;Cox G;Hayes M;Goodsaid F;Tandon PK;Furlong P;Boynton S;Bozic M;Orfali M;Thornton M
通讯作者：
Thornton M
影响因子：
5.8
作者：
Humbert, Olivier;Cochet, Alexandre;Fumoleau, Pierre
通讯作者：
Fumoleau, Pierre
影响因子：
158.5
作者：
Anderson, Monique L.;Chiswell, Karen;Califf, Robert M.
通讯作者：
Califf, Robert M.