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European Journal of Nuclear Medicine and Molecular Imaging

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Open Access 01-05-2022 | Original Article

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

Authors: Elizabeth J. de Koster, Lioe-Fee de Geus-Oei, Adrienne H. Brouwers, Eveline W. C. M. van Dam, Lioe-Ting Dijkhorst-Oei, Adriana C. H. van Engen-van Grunsven, Wilbert B. van den Hout, Tamira K. Klooker, Romana T. Netea-Maier, Marieke Snel, Wim J. G. Oyen, Dennis Vriens, for the EfFECTS trial study group

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 6/2022

Abstract

Purpose

To assess the impact of an [¹⁸F]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 [¹⁸F]FDG-PET/CT and were randomised to an [¹⁸F]FDG-PET/CT-driven or diagnostic surgery group. In the [¹⁸F]FDG-PET/CT-driven group, management was based on the [¹⁸F]FDG-PET/CT result: when the index nodule was visually [¹⁸F]FDG-positive, diagnostic surgery was advised; when [¹⁸F]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-Hürthle cell and Hürthle cell nodules.

Results

Patient management was unbeneficial in 42% (38/91 [95% confidence interval [CI], 32–53%]) of patients in the [¹⁸F]FDG-PET/CT-driven group, as compared to 83% (34/41 [95% CI, 68–93%]) in the diagnostic surgery group (p < 0.001). [¹⁸F]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-Hürthle cell and 13% (2/15 [95% CI, 2–40%]) in Hürthle 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 [¹⁸F]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 [¹⁸F]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-Hürthle cell nodules.

Trial registration number

This trial is registered with ClinicalTrials.gov: NCT02208544 (5 August 2014), https://clinicaltrials.gov/ct2/show/NCT02208544.

Available only for authorised users

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Title: [18F]FDG-PET/CT to prevent futile surgery in indeterminate thyroid nodules: a blinded, randomised controlled multicentre trial
Authors: Elizabeth J. de Koster
Lioe-Fee de Geus-Oei
Adrienne H. Brouwers
Eveline W. C. M. van Dam
Lioe-Ting Dijkhorst-Oei
Adriana C. H. van Engen-van Grunsven
Wilbert B. van den Hout
Tamira K. Klooker
Romana T. Netea-Maier
Marieke Snel
Wim J. G. Oyen
Dennis Vriens
for the EfFECTS trial study group
Publication date: 01-05-2022
Publisher: Springer Berlin Heidelberg
Published in: European Journal of Nuclear Medicine and Molecular Imaging / Issue 6/2022
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-021-05627-2

At a glance: The STEP trials

Springer Medicine

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

Abstract

Purpose

Methods

Results

Conclusion

Trial registration number

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration number

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