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Clinical Trial
. 2021 May;48(5):1560-1569.
doi: 10.1007/s00259-020-05089-y. Epub 2020 Nov 1.

Impact of solitary pulmonary nodule size on qualitative and quantitative assessment using 18F-fluorodeoxyglucose PET/CT: the SPUTNIK trial

J R Weir-McCall  1   2 , S Harris  3 , K A Miles  4 , N R Qureshi  2 , R C Rintoul  5 , S Dizdarevic  6 , L Pike  7 , Heok K Cheow  8 , Fiona J Gilbert  9 ; SPUtNIk investigators
Collaborators, Affiliations
Clinical Trial

Impact of solitary pulmonary nodule size on qualitative and quantitative assessment using 18F-fluorodeoxyglucose PET/CT: the SPUTNIK trial

J R Weir-McCall et al. Eur J Nucl Med Mol Imaging. 2021 May.

Abstract

Purpose: To compare qualitative and semi-quantitative PET/CT criteria, and the impact of nodule size on the diagnosis of solitary pulmonary nodules in a prospective multicentre trial.

Methods: Patients with an SPN on CT ≥ 8 and ≤ 30 mm were recruited to the SPUTNIK trial at 16 sites accredited by the UK PET Core Lab. Qualitative assessment used a five-point ordinal PET-grade compared to the mediastinal blood pool, and a combined PET/CT grade using the CT features. Semi-quantitative measures included SUVmax of the nodule, and as an uptake ratio to the mediastinal blood pool (SURBLOOD) or liver (SURLIVER). The endpoints were diagnosis of lung cancer via biopsy/histology or completion of 2-year follow-up. Impact of nodule size was analysed by comparison between nodule size tertiles.

Results: Three hundred fifty-five participants completed PET/CT and 2-year follow-up, with 59% (209/355) malignant nodules. The AUCs of the three techniques were SUVmax 0.87 (95% CI 0.83;0.91); SURBLOOD 0.87 (95% CI 0.83; 0.91, p = 0.30 versus SUVmax); and SURLIVER 0.87 (95% CI 0.83; 0.91, p = 0.09 vs. SUVmax). The AUCs for all techniques remained stable across size tertiles (p > 0.1 for difference), although the optimal diagnostic threshold varied by size. For nodules < 12 mm, an SUVmax of 1.75 or visual uptake equal to the mediastinum yielded the highest accuracy. For nodules > 16 mm, an SUVmax ≥ 3.6 or visual PET uptake greater than the mediastinum was the most accurate.

Conclusion: In this multicentre trial, SUVmax was the most accurate technique for the diagnosis of solitary pulmonary nodules. Diagnostic thresholds should be altered according to nodule size.

Trial registration: ISRCTN - ISRCTN30784948. ClinicalTrials.gov - NCT02013063.

Keywords: Cost-effectiveness; DCE-CT; Diagnostic accuracy trial; Diagnostic imaging; Lung cancer; PET/CT; Solitary pulmonary nodule (SPN).

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
STARD flow diagram of the study recruitment and follow-up. CT—computed tomography; DCE-CT—dynamic contrast enhanced computed tomography; PET—positron emission tomography
Fig. 2
Fig. 2
Receiver operator characteristic curve for the diagnosis of malignancy by SUVmax, SURBLOOD, SURLIVER and PET grade
Fig. 3
Fig. 3
Box and whisker plot of SUVmax by nodule size tertile and malignancy status. B = Benign, M = Malignant. Thick central band = median; upper and lower bound of box = 75th and 25th centiles respectively, whiskers reflecting upper and lower limits, with dots reflecting outliers
See this image and copyright information in PMC

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