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Prevalence of clinically significant incidental findings by whole-body fludeoxyglucose F 18 positron emission tomography/computed tomography scanning in moderate-to-severe psoriasis patients participating in clinical trials.
Journal of the American Academy of Dermatology ( IF 13.8 ) Pub Date : 2019-01-14 , DOI: 10.1016/j.jaad.2019.01.008
Marilyn T Wan 1 , Drew A Torigian 2 , Abass Alavi 2 , Judith Alvarez 1 , Zelma C Chiesa Fuxench 1 , Megan H Noe 1 , Maryte Papadopoulos 1 , Daniel B Shin 1 , Junko Takeshita 3 , Thomas J Werner 2 , Nehal N Mehta 4 , Joel M Gelfand 3
Affiliation  

Background

There has been an increase in the number of psoriasis treatments being investigated in clinical trials. Patients may have undiagnosed issues at the start of a study which may become identified during follow-up as incident medicinal conditions. The prevalence of incidental findings in patients with moderate-to-severe psoriasis presenting for clinical trials is unknown.

Objective

Determine the prevalence of incidentalomas and rate of malignancy identified by fludeoxyglucose F 18 (FDG) positron emission tomography/computed tomography (PET/CT) imaging in clinical trial patients with moderate-to-severe psoriasis.

Methods

A cross-sectional secondary analysis of patients with moderate-to-severe psoriasis who underwent FDG PET/CT scans at the baseline visit, before randomization, for 3 phase 4 clinical trials on vascular inflammation in psoriasis. Only patients without active infection, malignancy, or uncontrolled comorbidities were eligible for the clinical trials.

Results

A total of 259 healthy patients with moderate-to-severe psoriasis underwent an FDG PET/CT scan as part of the study procedures. In all, 31 patients (11.97%) (95% confidence interval [CI], 8.28-16.56) had clinically significant incidentalomas on the baseline FDG PET/CT scan. Univariate logistic regression demonstrated that with every increase of 10 years of age, there was an approximate 30% increased risk of discovery of an incidentaloma (odds ratio, 1.30; 95% CI, 1.01-1.68). Of those patients with findings suggestive of malignancy (n = 28), 6 were confirmed to have cancer, resulting in a 2.31% (95% CI, 0.9-5.0) prevalence of malignancy. The positive predictive value of a true cancer was 31.58% (range, 21%-54%).

Limitations

Generalizability and lost to follow-up.

Conclusion

Incidentalomas on FDG PET/CT imaging are common in otherwise healthy, asymptomatic patients with moderate-to-severe psoriasis in clinical trials. Our results can help inform interpretation of clinical trial safety data and emphasize the importance of compliance with cancer screening recommendations.



中文翻译:

在参加临床试验的中至重度牛皮癣患者中,全身性氟氧葡萄糖F 18正电子发射断层显像/计算机断层摄影扫描对临床上重要的偶然发现的发生率。

背景

在临床试验中研究的牛皮癣治疗的数量已经增加。在研究开始时,患者可能有未诊断的问题,这些问题可能会在随访过程中被确定为突发性医学病症。目前尚不明确的中度至重度牛皮癣患者临床研究中偶然发现的患病率。

客观的

确定在中至重度牛皮癣的临床试验患者中,通过氟氧葡萄糖F 18(FDG)正电子发射断层扫描/计算机断层扫描(PET / CT)成像确定的偶发瘤患病率和恶性程度。

方法

对中度至重度银屑病患者的横断面二级分析,在基线前就诊时接受了FDG PET / CT扫描,然后随机分组,进行了有关银屑病血管炎症的3期4期临床试验。只有没有活动性感染,恶性肿瘤或无法控制的合并症的患者才有资格进行临床试验。

结果

作为研究程序的一部分,共有259名中度至重度牛皮癣的健康患者接受了FDG PET / CT扫描。在基线FDG PET / CT扫描中,共有31例患者(11.97%)(95%置信区间[CI],8.28-16.56)有临床上显着的偶发瘤。单因素逻辑回归分析表明,每增加10岁,发现偶发瘤的风险大约增加30%(比值比为1.30; 95%CI为1.01-1.68)。在那些发现有恶性肿瘤的患者中(n = 28),有6名被证实患有癌症,导致恶性肿瘤的患病率为2.31%(95%CI,0.9-5.0)。真实癌症的阳性预测值为31.58%(范围为21%-54%)。

局限性

普遍性和失去后续行动。

结论

在临床试验中,FDG PET / CT成像中的偶然事件在其他健康,无症状的中度至重度牛皮癣患者中很常见。我们的结果可有助于为临床试验安全性数据提供解释,并强调遵守癌症筛查建议的重要性。

更新日期:2019-01-14
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