{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Wan MT"],"funding":["National Psoriasis Foundation","Ortho Dermatologic","Novartis Pharmaceuticals","Celgene","Pfizer","NHLBI NIH HHS","National Heart, Lung, and Blood Institute","Ortho Dermatologics","National Institutes of Health","AbbVie","Eli Lilly and Company","Abbvie","Novartis","Janssen","Janssen Scientific Affairs","NIAMS NIH HHS"],"pagination":["1630-1639"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6536299"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["80(6)"],"pubmed_abstract":["<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Limitations</h4>Generalizability and lost to follow-up.<h4>Conclusion</h4>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."],"journal":["Journal of the American Academy of Dermatology"],"pubmed_title":["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."],"pmcid":["PMC6536299"],"funding_grant_id":["5P30AR069589-03","R01 HL111293","P30 AR069589","R01- HL111293"],"pubmed_authors":["Alvarez J","Papadopoulos M","Torigian DA","Noe MH","Shin DB","Alavi A","Mehta NN","Takeshita J","Werner TJ","Wan MT","Chiesa Fuxench ZC","Gelfand JM"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Limitations</h4>Generalizability and lost to follow-up.<h4>Conclusion</h4>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.","dates":{"release":"2019-01-01T00:00:00Z","publication":"2019 Jun","modification":"2024-11-13T12:03:01.441Z","creation":"2020-06-04T07:11:00Z"},"accession":"S-EPMC6536299","cross_references":{"pubmed":["30654078"],"doi":["10.1016/j.jaad.2019.01.008"]}}