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.
Adult
Aged
Asymptomatic Diseases
Clinical Trials as Topic
Comorbidity
Cross-Sectional Studies
Ethnicity
Female
Fluorine Radioisotopes
Fluorodeoxyglucose F18
Humans
Incidental Findings
Male
Middle Aged
Neoplasms
/ diagnostic imaging
Positron Emission Tomography Computed Tomography
Predictive Value of Tests
Prevalence
Psoriasis
/ complications
Radiopharmaceuticals
Severity of Illness Index
Smoking
/ epidemiology
Whole Body Imaging
FDG PET/CT
biologics
incidental findings
psoriasis
randomized controlled trials
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Jun 2019
Jun 2019
Historique:
received:
19
11
2018
revised:
17
12
2018
accepted:
06
01
2019
pubmed:
18
1
2019
medline:
29
10
2019
entrez:
18
1
2019
Statut:
ppublish
Résumé
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. 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. 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. 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%). Generalizability and lost to follow-up. 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.
Sections du résumé
BACKGROUND
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
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
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
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
CONCLUSIONS
Generalizability and lost to follow-up.
CONCLUSION
CONCLUSIONS
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.
Identifiants
pubmed: 30654078
pii: S0190-9622(19)30078-7
doi: 10.1016/j.jaad.2019.01.008
pmc: PMC6536299
mid: NIHMS1527323
pii:
doi:
Substances chimiques
Fluorine Radioisotopes
0
Radiopharmaceuticals
0
Fluorodeoxyglucose F18
0Z5B2CJX4D
Fluorine-18
GZ5I74KB8G
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1630-1639Subventions
Organisme : NIAMS NIH HHS
ID : P30 AR069589
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL111293
Pays : United States
Informations de copyright
Copyright © 2019 American Academy of Dermatology, Inc. All rights reserved.
Références
Crit Care Med. 2003 Mar;31(3 Suppl):S121-5
pubmed: 12626956
Arch Dermatol. 2005 Dec;141(12):1537-41
pubmed: 16365254
Science. 2006 Feb 10;311(5762):783-4
pubmed: 16469905
JAMA. 2006 Oct 11;296(14):1735-41
pubmed: 17032986
Lancet. 2007 Oct 20;370(9596):1453-7
pubmed: 18064739
J Law Med Ethics. 2008 Summer;36(2):219-48, 211
pubmed: 18547191
Br J Radiol. 2010 Apr;83(988):276-89
pubmed: 20335439
Surgery. 2010 Oct;148(4):618-24
pubmed: 20705305
Ann Saudi Med. 2011 Jan-Feb;31(1):3-13
pubmed: 21245592
J Cardiovasc Magn Reson. 2013 May 28;15:46
pubmed: 23714095
JAMA Dermatol. 2013 Oct;149(10):1173-9
pubmed: 23925466
Injury. 2014 May;45(5):840-4
pubmed: 24252575
JACC Cardiovasc Imaging. 2013 Dec;6(12):1250-9
pubmed: 24269261
CMAJ. 2014 Jun 10;186(9):655-6
pubmed: 24688013
Br J Dermatol. 2015;172(5):1395-406
pubmed: 25418186
J Am Acad Dermatol. 2017 Mar;76(3):377-390
pubmed: 28212759
J Am Acad Dermatol. 2018 Feb;78(2):315-322.e1
pubmed: 29128465
Br J Dermatol. 2018 Jan;178(1):19
pubmed: 29357587
Ann Intern Med. 2018 Jun 5;168(11):820-821
pubmed: 29710065
Circ Cardiovasc Imaging. 2018 Jun;11(6):e007394
pubmed: 29776990
CA Cancer J Clin. 2018 Jul;68(4):297-316
pubmed: 29846940
BMJ. 2018 Jun 18;361:k2387
pubmed: 29914908