Whole-body 18F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer: A randomized prospective study of 200 patients

Anne Mette Lebech; Anne Gaardsting; Annika Loft; Jesper Graff; Elena Markova; Anne Kiil Bertelsen; Jan Lysgard Madsen; Kim Francis Andersen; Eric Von Benzon; Morten Helms; Lars R. Mathiesen; Kim P. David; Gitte Kronborg; Andreas Kjaer

doi:10.2967/jnumed.116.175380

Whole-body ¹⁸F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer: A randomized prospective study of 200 patients

Anne Mette Lebech, Anne Gaardsting, Annika Loft, Jesper Graff, Elena Markova, Anne Kiil Bertelsen, Jan Lysgard Madsen, Kim Francis Andersen, Eric Von Benzon, Morten Helms, Lars R. Mathiesen, Kim P. David, Gitte Kronborg, Andreas Kjaer^*

^*Corresponding author for this work

17 Citations (Scopus)

Abstract

A fast-track pathway has been established in Denmark to investigate patients with serious nonspecific symptoms and signs of cancer (NSSC), who are not eligible to enter an organ-specific cancer program. The prevalence of cancer in this cohort is approximately 20%. The optimal screening strategy in patients with NSSC remains unknown. The aim of the study was to investigate whether ¹⁸F-FDG PET/CT was superior to CT as an initial imaging modality in patients with NSSC. In a randomized prospective trial, the imaging modalities were compared with regard to diagnostic performance. Methods: Two hundred patients were randomized 1:1 to whole-body ¹⁸F-FDG PET/CT or CT of the thorax and abdomen as the imaging modality. A tentative diagnosis was established after first-line imaging. The final referral diagnosis was adjudicated by the physician, when sufficient data were available. Results: One hundred ninety-seven patients were available for analysis because 3 patients withdrew consent before scanning. Thirty-nine (20%) patients were diagnosed with cancer, 10 (5%) with an infection, 15 (8%) with an autoimmune disease, and 76 (39%) with other diseases. In the remaining 57 patients (28%), no specific disease was found. ¹⁸F-FDG PET/CT had a higher specificity (96% vs. 85%; P 5 0.028) and a higher accuracy (94% vs. 82%; P 5 0.017) than CT. However, there were no statistically significant differences in sensitivity (83% vs. 70%) or negative predictive values (96% vs. 92%). No difference in days to final referral diagnosis according to randomization group could be shown (7.2 vs. 7.6 d). However, for the subgroups in which the imaging modality showed a suggestion of malignancy, there was a significant delay to final diagnosis in the CT group compared with the ¹⁸F-FDG PET/CT group (11.6 vs. 5.7 d; P 5 0.02). Conclusion: Compared with CT, we found a higher diagnostic specificity and accuracy of ¹⁸F-FDG PET/CT for detecting cancer in patients with NSSC. ¹⁸F-FDG PET/CT should therefore be considered as first-line imaging in this group of patients.

Original language	English
Journal	Journal of Nuclear Medicine
Volume	58
Issue number	7
Pages (from-to)	1058-1064
Number of pages	7
ISSN	0161-5505
DOIs	https://doi.org/10.2967/jnumed.116.175380
Publication status	Published - Jul 2017

Keywords

FDG-PET/CT; molecular imaging; cancer; prospective study; randomized study

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Lebech, A. M., Gaardsting, A., Loft, A., Graff, J., Markova, E., Bertelsen, A. K., Madsen, J. L., Andersen, K. F., Von Benzon, E., Helms, M., Mathiesen, L. R., David, K. P., Kronborg, G., & Kjaer, A. (2017). Whole-body ¹⁸F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer: A randomized prospective study of 200 patients. Journal of Nuclear Medicine, 58(7), 1058-1064. https://doi.org/10.2967/jnumed.116.175380

Whole-body ¹⁸F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer: A randomized prospective study of 200 patients. / Lebech, Anne Mette; Gaardsting, Anne; Loft, Annika et al.
In: Journal of Nuclear Medicine, Vol. 58, No. 7, 07.2017, p. 1058-1064.

Research output: Contribution to journal › Journal article › Research › peer-review

Lebech, AM, Gaardsting, A, Loft, A, Graff, J, Markova, E, Bertelsen, AK, Madsen, JL, Andersen, KF, Von Benzon, E, Helms, M, Mathiesen, LR, David, KP, Kronborg, G & Kjaer, A 2017, 'Whole-body ¹⁸F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer: A randomized prospective study of 200 patients', Journal of Nuclear Medicine, vol. 58, no. 7, pp. 1058-1064. https://doi.org/10.2967/jnumed.116.175380

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title = "Whole-body 18F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer: A randomized prospective study of 200 patients",

abstract = "A fast-track pathway has been established in Denmark to investigate patients with serious nonspecific symptoms and signs of cancer (NSSC), who are not eligible to enter an organ-specific cancer program. The prevalence of cancer in this cohort is approximately 20%. The optimal screening strategy in patients with NSSC remains unknown. The aim of the study was to investigate whether 18F-FDG PET/CT was superior to CT as an initial imaging modality in patients with NSSC. In a randomized prospective trial, the imaging modalities were compared with regard to diagnostic performance. Methods: Two hundred patients were randomized 1:1 to whole-body 18F-FDG PET/CT or CT of the thorax and abdomen as the imaging modality. A tentative diagnosis was established after first-line imaging. The final referral diagnosis was adjudicated by the physician, when sufficient data were available. Results: One hundred ninety-seven patients were available for analysis because 3 patients withdrew consent before scanning. Thirty-nine (20%) patients were diagnosed with cancer, 10 (5%) with an infection, 15 (8%) with an autoimmune disease, and 76 (39%) with other diseases. In the remaining 57 patients (28%), no specific disease was found. 18F-FDG PET/CT had a higher specificity (96% vs. 85%; P 5 0.028) and a higher accuracy (94% vs. 82%; P 5 0.017) than CT. However, there were no statistically significant differences in sensitivity (83% vs. 70%) or negative predictive values (96% vs. 92%). No difference in days to final referral diagnosis according to randomization group could be shown (7.2 vs. 7.6 d). However, for the subgroups in which the imaging modality showed a suggestion of malignancy, there was a significant delay to final diagnosis in the CT group compared with the 18F-FDG PET/CT group (11.6 vs. 5.7 d; P 5 0.02). Conclusion: Compared with CT, we found a higher diagnostic specificity and accuracy of 18F-FDG PET/CT for detecting cancer in patients with NSSC. 18F-FDG PET/CT should therefore be considered as first-line imaging in this group of patients.",

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author = "Lebech, {Anne Mette} and Anne Gaardsting and Annika Loft and Jesper Graff and Elena Markova and Bertelsen, {Anne Kiil} and Madsen, {Jan Lysgard} and Andersen, {Kim Francis} and {Von Benzon}, Eric and Morten Helms and Mathiesen, {Lars R.} and David, {Kim P.} and Gitte Kronborg and Andreas Kjaer",

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T1 - Whole-body 18F-FDG PET/CT is superior to CT as first-line diagnostic imaging in patients referred with serious nonspecific symptoms or signs of cancer

T2 - A randomized prospective study of 200 patients

AU - Lebech, Anne Mette

AU - Gaardsting, Anne

AU - Loft, Annika

AU - Graff, Jesper

AU - Markova, Elena

AU - Bertelsen, Anne Kiil

AU - Madsen, Jan Lysgard

AU - Andersen, Kim Francis

AU - Von Benzon, Eric

AU - Helms, Morten

AU - Mathiesen, Lars R.

AU - David, Kim P.

AU - Kronborg, Gitte

AU - Kjaer, Andreas

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N2 - A fast-track pathway has been established in Denmark to investigate patients with serious nonspecific symptoms and signs of cancer (NSSC), who are not eligible to enter an organ-specific cancer program. The prevalence of cancer in this cohort is approximately 20%. The optimal screening strategy in patients with NSSC remains unknown. The aim of the study was to investigate whether 18F-FDG PET/CT was superior to CT as an initial imaging modality in patients with NSSC. In a randomized prospective trial, the imaging modalities were compared with regard to diagnostic performance. Methods: Two hundred patients were randomized 1:1 to whole-body 18F-FDG PET/CT or CT of the thorax and abdomen as the imaging modality. A tentative diagnosis was established after first-line imaging. The final referral diagnosis was adjudicated by the physician, when sufficient data were available. Results: One hundred ninety-seven patients were available for analysis because 3 patients withdrew consent before scanning. Thirty-nine (20%) patients were diagnosed with cancer, 10 (5%) with an infection, 15 (8%) with an autoimmune disease, and 76 (39%) with other diseases. In the remaining 57 patients (28%), no specific disease was found. 18F-FDG PET/CT had a higher specificity (96% vs. 85%; P 5 0.028) and a higher accuracy (94% vs. 82%; P 5 0.017) than CT. However, there were no statistically significant differences in sensitivity (83% vs. 70%) or negative predictive values (96% vs. 92%). No difference in days to final referral diagnosis according to randomization group could be shown (7.2 vs. 7.6 d). However, for the subgroups in which the imaging modality showed a suggestion of malignancy, there was a significant delay to final diagnosis in the CT group compared with the 18F-FDG PET/CT group (11.6 vs. 5.7 d; P 5 0.02). Conclusion: Compared with CT, we found a higher diagnostic specificity and accuracy of 18F-FDG PET/CT for detecting cancer in patients with NSSC. 18F-FDG PET/CT should therefore be considered as first-line imaging in this group of patients.

AB - A fast-track pathway has been established in Denmark to investigate patients with serious nonspecific symptoms and signs of cancer (NSSC), who are not eligible to enter an organ-specific cancer program. The prevalence of cancer in this cohort is approximately 20%. The optimal screening strategy in patients with NSSC remains unknown. The aim of the study was to investigate whether 18F-FDG PET/CT was superior to CT as an initial imaging modality in patients with NSSC. In a randomized prospective trial, the imaging modalities were compared with regard to diagnostic performance. Methods: Two hundred patients were randomized 1:1 to whole-body 18F-FDG PET/CT or CT of the thorax and abdomen as the imaging modality. A tentative diagnosis was established after first-line imaging. The final referral diagnosis was adjudicated by the physician, when sufficient data were available. Results: One hundred ninety-seven patients were available for analysis because 3 patients withdrew consent before scanning. Thirty-nine (20%) patients were diagnosed with cancer, 10 (5%) with an infection, 15 (8%) with an autoimmune disease, and 76 (39%) with other diseases. In the remaining 57 patients (28%), no specific disease was found. 18F-FDG PET/CT had a higher specificity (96% vs. 85%; P 5 0.028) and a higher accuracy (94% vs. 82%; P 5 0.017) than CT. However, there were no statistically significant differences in sensitivity (83% vs. 70%) or negative predictive values (96% vs. 92%). No difference in days to final referral diagnosis according to randomization group could be shown (7.2 vs. 7.6 d). However, for the subgroups in which the imaging modality showed a suggestion of malignancy, there was a significant delay to final diagnosis in the CT group compared with the 18F-FDG PET/CT group (11.6 vs. 5.7 d; P 5 0.02). Conclusion: Compared with CT, we found a higher diagnostic specificity and accuracy of 18F-FDG PET/CT for detecting cancer in patients with NSSC. 18F-FDG PET/CT should therefore be considered as first-line imaging in this group of patients.

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