[18F]FDG-PET/CT to prevent futile surgery in indeterminate thyroid nodules: a blinded, randomised controlled multicentre trial

被引:27
作者
de Koster, Elizabeth J. [1 ]
de Geus-Oei, Lioe-Fee [1 ,2 ,3 ]
Brouwers, Adrienne H. [4 ]
van Dam, Eveline W. C. M. [5 ]
Dijkhorst-Oei, Lioe-Ting [6 ]
van Engen-van Grunsven, Adriana C. H. [7 ]
van den Hout, Wilbert B. [8 ]
Klooker, Tamira K. [9 ,10 ]
Netea-Maier, Romana T. [11 ]
Snel, Marieke [12 ]
Oyen, Wim J. G. [1 ,13 ,14 ,15 ]
Vriens, Dennis [2 ]
机构
[1] Radboud Univ Nijmegen, Dept Radiol & Nucl Med, Med Ctr, Nijmegen, Netherlands
[2] Leiden Univ, Dept Radiol, Sect Nucl Med, Med Ctr, Leiden, Netherlands
[3] Univ Twente, Biomed Photon Imaging Grp, Enschede, Netherlands
[4] Univ Groningen, Univ Med Ctr Groningen, Dept Nucl Med & Mol Imaging Groningen, Groningen, Netherlands
[5] Univ Amsterdam, Locat VU Med Ctr, Dept Internal Med, Div Endocrinol,Med Ctr, Amsterdam, Netherlands
[6] Meander Med Ctr, Dept Internal Med, Amersfoort, Netherlands
[7] Radboud Univ Nijmegen, Dept Pathol, Med Ctr, Nijmegen, Netherlands
[8] Leiden Univ, Dept Med Decis Making, Med Ctr, Leiden, Netherlands
[9] Univ Amsterdam, Locat Acad Med Ctr, Dept Endocrinol & Metab, Amsterdam Gastroenterol Endocrinol & Metab,Med Ct, Amsterdam, Netherlands
[10] Flevo Hosp, Dept Internal Med, Almere, Netherlands
[11] Radboud Univ Nijmegen, Dept Internal Med, Div Endocrinol, Med Ctr, Nijmegen, Netherlands
[12] Leiden Univ, Dept Med, Div Endocrinol, Med Ctr, Leiden, Netherlands
[13] Rijnstate Hosp, Dept Radiol & Nucl Med, Arnhem, Netherlands
[14] Humanitas Univ, Dept Biomed Sci, Milan, Italy
[15] Humanitas Univ, Humanitas Clin & Res Ctr, Milan, Italy
关键词
F-18]FDG-PET/CT; Indeterminate; Thyroid nodule; Thyroid carcinoma; Thyroid cytology; Thyroid surgery; ASSOCIATION GUIDELINES; COST-EFFECTIVENESS; HURTHLE CELL; TASK-FORCE; FDG-PET/CT; MANAGEMENT; CANCER; DIAGNOSIS;
D O I
10.1007/s00259-021-05627-2
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
Purpose To assess the impact of an [F-18]FDG-PET/CT-driven diagnostic workup to rule out malignancy, avoid futile diagnostic surgeries, and improve patient outcomes in thyroid nodules with indeterminate cytology. Methods In this double-blinded, randomised controlled multicentre trial, 132 adult euthyroid patients with scheduled diagnostic surgery for a Bethesda III or IV thyroid nodule underwent [F-18]FDG-PET/CT and were randomised to an [F-18] FDG-PET/CT-driven or diagnostic surgery group. In the [F-18]FDG-PET/CT-driven group, management was based on the [F-18]FDG-PET/CT result: when the index nodule was visually [F-18]FDG-positive, diagnostic surgery was advised; when [F-18]FDG-negative, active surveillance was recommended. The nodule was presumed benign when it remained unchanged on ultrasound surveillance. In the diagnostic surgery group, all patients were advised to proceed to the scheduled surgery, according to current guidelines. The primary outcome was the fraction of unbeneficial patient management in one year, i.e., diagnostic surgery for benign nodules and active surveillance for malignant/borderline nodules. Intention-to-treat analysis was performed. Subgroup analyses were performed for non-Hurthle cell and Hurthle cell nodules. Results Patient management was unbeneficial in 42% (38/91 [95% confidence interval [CI], 32-53%]) of patients in the [F-18] FDG-PET/CT-driven group, as compared to 83% (34/41 [95% CI, 68-93%]) in the diagnostic surgery group (p < 0.001). [F-18]FDG-PET/CT-driven management avoided 40% (25/63 [95% CI, 28-53%]) diagnostic surgeries for benign nodules: 48% (23/48 [95% CI, 33-63%]) in non-Hurthle cell and 13% (2/15 [95% CI, 2-40%]) in I-Liable cell nodules (p = 0.02). No malignant or borderline tumours were observed in patients under surveillance. Sensitivity, specificity, negative and positive predictive value, and benign call rate (95% CI) of [F-18]FDG-PET/CT were 94.1% (80.3-99.3%), 39.8% (30.0-50.2%), 95.1% (83.5-99.4%), 35.2% (25.4-45.9%), and 31.1% (23.3-39.7%), respectively. Conclusion An [F-18]FDG-PET/CT-driven diagnostic workup of indeterminate thyroid nodules leads to practice changing management, accurately and oncologically safely reducing futile surgeries by 40%. For optimal therapeutic yield, application should be limited to non-Hurthle cell nodules.
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收藏
页码:1970 / 1984
页数:15
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