22 februari 2022: Bron: European Journal of Nuclear Medicine and Molecular Imaging (2022)

Wanneer bij mensen met schildklierknobbeltjes Bethesda III of IV vooraf aan de geplande operatie een nauwkeuriger diagnose werd gedaan met een FDG-PET/CT-scan dan bleek 42 procent van de operaties niet nodig te zijn omdat de knobbeltjes goedaardig bleken. Hiermee werd dus het verschil tussen goedaardige en kwaadaardige knobbeltjes aangetoond met alle gevolgen vandien voor de patiënt. Zij kregen dus veel meer zekerheid welke behandeling nodig was. 

Het primaire doel van de Nederlandse studie was het nauwkeurig verminderen van ongunstige patiëntenzorg, d.w.z. het vermijden van diagnostische chirurgie voor goedaardige knobbeltjes en het vermijden van surveillance voor kwaadaardige en borderline knobbeltjes die een chirurgische ingreep vereisen.
Secundaire doelstellingen waren het bepalen van de impact van FDG-PET/CT-gestuurd management op het aantal chirurgische complicaties, HRQoL - kwaliteit van leven, maatschappelijke kosten en gevolgen van incidentele PET/CT-bevindingen en het beoordelen van de implementeerbaarheid van FDG-PET /CT.

Vertaalde resultaten uit het abstract:
  • Patiëntenbehandeling was niet gunstig bij 42% (38/91 [95% betrouwbaarheidsinterval , 32-53%]) van de patiënten in de FDG-PET/CT-aangedreven groep, vergeleken met 83% (34/ 41 [95% BI, 68-93%]) in de groep voor diagnostische chirurgie (p < 0,001).
  • FDG-PET/CT-gestuurde behandeling vermeden 40% (25/63 [95% BI, 28–53%]) diagnostische operaties voor goedaardige knobbeltjes: 48% (23/48 [95% BI, 33–63%] ]) in niet-Hürthle-cellen en 13% (2/15 [95% BI, 2-40%]) in Hürthle-celknobbeltjes (p = 0.02).
  • Er werden geen kwaadaardige of borderline-tumoren waargenomen bij patiënten onder toezicht.
  • Gevoeligheid, specificiteit, negatief en positief voorspellende waarde en goedaardige call rate (95% BI) van FDG-PET/CT waren 94,1% (80,3-99,3%), 39,8% (30,0-50,2%), 95,1% ( 83,5-99,4%), 35,2% (25,4-45,9%) en 31,1% (23,3-39,7%), respectievelijk.

figure 1
Trial profile. The dashed line indicates the patients who deviated from the treatment advise per protocol. NIFTP, non-invasive follicular thyroid neoplasm with papillary-like nuclear features. FT-UMP-OV, follicular tumour of uncertain malignant potential, Hürthle cell type. *: a specification of reasons for ineligibility is provided in Supplementary Table 2

Conclusie:
Een FDG-PET/CT-gestuurde diagnostische verbetering van onbepaalde schildklierknobbeltjes leidt tot praktijkverandering van management, is nauwkeurig en oncologisch veilig, waardoor nutteloze operaties met 40% kunnen worden verminderd. Voor een optimale therapeutische opbrengst zou de toepassing van de FDG-PET/CT kunnen worden beperkt tot niet-Hürthle-celknobbeltjes.

Het volledige studierapport is gratis in te zien of te downloaden. Klik daarvoor op de titel van het abstract:

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

European Journal of Nuclear Medicine and Molecular Imaging (2022)Cite this article

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 , 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.

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Acknowledgements

The authors like to thank all the patients who participated in the EfFECTS trial, all members of the EfFECTS trial consortium, and all others who were involved in any of the study procedures. In particular, we like to thank Dr. B. Küsters (BK), a pathologist at the Radboud university medical centre, Nijmegen, the Netherlands, for his assistance with the central review of cytology and histopathology samples, and Prof. dr. O.M. Dekkers, a clinical epidemiologist and endocrinologist at the Leiden University Medical Center, Leiden, the Netherlands, and Prof. dr. H. Putter, a statistician at the Leiden University Medical Center, Leiden, the Netherlands, for their expertise and guidance during the execution of the trial.

Funding

The EfFECTS trial was supported by a project grant from the Dutch Cancer Society (KUN 2014–6514).

Author information

Affiliations

  1. Department of Radiology and Nuclear Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands

    Elizabeth J. de Koster, Lioe-Fee de Geus-Oei & Wim J. G. Oyen

  2. Department of Radiology, Section of Nuclear Medicine, Leiden University Medical Center, Leiden, the Netherlands

    Lioe-Fee de Geus-Oei & Dennis Vriens

  3. Biomedical Photonic Imaging Group, University of Twente, Enschede, the Netherlands

    Lioe-Fee de Geus-Oei

  4. Department of Nuclear Medicine and Molecular Imaging Groningen, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands

    Adrienne H. Brouwers

  5. Department of Internal Medicine, Division of Endocrinology, Amsterdam University Medical Centers, Location VU Medical Center, Amsterdam, the Netherlands

    Eveline W. C. M. van Dam

  6. Department of Internal Medicine, Meander Medical Centre, Amersfoort, the Netherlands

    Lioe-Ting Dijkhorst-Oei

  7. Department of Pathology, Radboud University Medical Centre, Nijmegen, the Netherlands

    Adriana C. H. van Engen-van Grunsven

  8. Department of Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands

    Wilbert B. van den Hout

  9. Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam University Medical Centers, Location Academic Medical Center, Amsterdam, the Netherlands

    Tamira K. Klooker

  10. Department of Internal Medicine, Flevo Hospital, Almere, the Netherlands

    Tamira K. Klooker

  11. Department of Internal Medicine, Division of Endocrinology, Radboud University Medical Centre, Nijmegen, the Netherlands

    Romana T. Netea-Maier

  12. Department of Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, the Netherlands

    Marieke Snel

  13. Department of Radiology and Nuclear Medicine, Rijnstate Hospital, Arnhem, the Netherlands

    Wim J. G. Oyen

  14. Department of Biomedical Sciences and Humanitas Clinical and Research Centre, Department of Nuclear Medicine, Humanitas University, Milan, Italy

    Wim J. G. Oyen

Consortia

for the EfFECTS trial study group

Contributions

Lioe-Fee de Geus-Oei, Wim J.G. Oyen, and Dennis Vriens conceptualised the study. Lioe-Fee de Geus-Oei was the project leader. Wim J.G. Oyen and Dennis Vriens were principal investigators. Elizabeth J. de Koster was the junior investigator. Adrienne H. Brouwers, Eveline W.C.M. van Dam, Lioe-Ting Dijkhorst-Oei, Tamira K. Klooker, Romana T. Netea-Maier, and Marieke Snel were local principal investigators in hospitals participating in the study. Adriana C.H. van Engen-van Grunsven was the principal central pathologist. Elizabeth J. de Koster prepared the dataset for analysis, drafted the manuscript and prepared the tables and figures. Elizabeth J. de Koster and Dennis Vriens verified the data and performed the statistical analysis. All authors contributed to data acquisition and the interpretation of the data, and critically reviewed this manuscript. All authors had full access to all the data in the study and approved the manuscript before submission. Dennis Vriens had final responsibility for the decision to submit for publication.

Corresponding author

Correspondence to Elizabeth J. de Koster.

Ethics declarations

Ethics approval

The study protocol was approved by the Medical Research Ethics Committee on Research Involving Human Subjects region Arnhem-Nijmegen, Nijmegen, the Netherlands, on 10 November 2014.

Consent to participate

Prior to any study activities, written informed consent was obtained from all individual participants included in the study.

Consent for publication

All patients signed informed consent regarding publishing their data.

Conflicts of interest

The authors have no conflicts of interest to declare that are relevant to the content of this article.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This article is part of the Topical Collection on Endocrinology.

[18F]FDG-PET/CT, diagnose, schildklierknobbeltjes, niet-Hürthle-celknobbeltjes, goedaardig, kwaadaardig, schildklierkanker


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