Prevalence of clinically significant incidental findings by whole-body FDG-PET/CT scanning in moderate-to-severe psoriasis patients participating in clinical trials

Publication date: Available online 14 January 2019

Source: Journal of the American Academy of Dermatology

Author(s): Marilyn T. Wan, Drew A. Torigian, Abass Alavi, Judith Alvarez, Zelma C. Chiesa Fuxench, Megan H. Noe, Maryte Papadopoulos, Daniel B. Shin, Junko Takeshita, Thomas J. Werner, Nehal N. Mehta, Joel M. Gelfand

Abstract

Objective

Determine the prevalence of incidentalomas and rate of malignancy identified by FDG-PET/CT imaging in clinical trial patients with moderate-to-severe psoriasis.

Methods

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

Results

259 healthy patients with moderate-to-severe psoriasis underwent an FDG-PET/CT scan as part of study procedures. Thirty-one 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 in 10 years of age, there was an approximate 30% increased risk of discovering an incidentaloma (Odds Ratio 1.30 [95%CI:1.01-1.68]). Of the findings suspicious for malignancy (n=28), cancer was confirmed in 6 patients resulting in a 2.31% (95%CI:0.9-5.0) prevalence of malignancy. 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 clinical trial patients with moderate-to-severe psoriasis. Our results can help inform clinical trials safety data interpretation and emphasizes the importance of compliance with cancer screening recommendations.

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