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

Autor: Zelma C. Chiesa Fuxench, Judith Alvarez, Drew A. Torigian, Daniel B. Shin, Maryte Papadopoulos, Abass Alavi, Marilyn T. Wan, Junko Takeshita, Nehal N. Mehta, Thomas Werner, Joel M. Gelfand, Megan H. Noe
Rok vydání: 2018
Předmět:
Adult
Male
medicine.medical_specialty
Fluorine Radioisotopes
Dermatology
Comorbidity
Malignancy
Severity of Illness Index
Article
law.invention
030207 dermatology & venereal diseases
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Psoriasis Area and Severity Index
Fluorodeoxyglucose F18
Predictive Value of Tests
Psoriasis
Neoplasms
Positron Emission Tomography Computed Tomography
medicine
Ethnicity
Prevalence
Humans
Whole Body Imaging
Aged
Clinical Trials as Topic
Incidental Findings
medicine.diagnostic_test
business.industry
Incidentaloma
Smoking
Odds ratio
Middle Aged
medicine.disease
Clinical trial
Cross-Sectional Studies
Positron emission tomography
030220 oncology & carcinogenesis
Asymptomatic Diseases
Female
Radiology
Radiopharmaceuticals
business
Zdroj: J Am Acad Dermatol
ISSN: 1097-6787
Popis: 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.
Databáze: OpenAIRE
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