The FUSION iENA Study: Comparison of I-124-PET/US Fusion Imaging with Conventional Diagnostics for the Functional Assessment of Thyroid Nodules by Multiple Observers

Abstract

Aim To investigate the value of I-124 positron emission tomography (PET) / ultrasound (US) fusion imaging in comparison to conventional diagnostics (CD) of Thyroid nodules (TN) by multiple observers.

Methods Digital patient case files (PCF) of patients that received CD and I-124-PET/US in clinical routine were prepared containing cine-loops of the examinations. All physicians with nuclear medicine specialty from Germany, Austria, and Switzerland were invited to participate. 106 acquired observers completed 7.2 ± 1.8 (median: 8, range: 4–14) randomly assigned PCF (CD only or CD+PET/US). They assessed the TN function, stated their confidence in functional assessment, and suggested a treatment course for each TN.

Results 68 PCF of 34 patients comprising 66 TN ≥ 1 cm (= 1.94 TN/patient) were created. A total of 748 (11.2/TN), and 751 ratings (11.4/TN) were recorded for CD only, and CD+PET/US, respectively. The functional assessment revealed more hyper- or hypofunctioning (524 vs. 320, p < 0.0001) and less indifferent or not rateable (209 vs. 428, p < 0.0001) TN in CD+PET/US vs. CD only. The observers’ confidence in functional assessment was superior in CD+PET/US (p < 0.0001). Furthermore, the ratings were carried out more homogeneous in CD+PET/US (p < 0.0001). Fewer suggestion of follow up (p < 0.0001), and more (p < 0.0001) suggestion of invasive treatments (fine-needle aspiration & surgery) was observed in CD+PET/US. Radioiodine therapy was more often (p = 0.0036), and thyroid medication less often (p = 0.0167) advised in CD+PET/US.

Conclusion Functional assessment of equivocal TN shows frequent failures in CD, underestimating the incidence of hyper- and hypofunctioning lesions. Confidence in functional assessment significantly increases with additional PET/US. This influences the proposed treatment course.

Zusammenfassung

Ziel Multi-Observer-Untersuchung des diagnostischen Mehrwerts der I-124-Positronenemissionstomografie (PET)/Ultraschall (US) -Fusionsbildgebung im Vergleich zur konventionellen Diagnostik (CD) bei der Funktionsbeurteilung von Schilddrüsenknoten.

Methoden Es erfolgte die Erstellung digitaler Patientenakten inklusive Filmsequenzen von Probanden, die im Rahmen der klinischen Routine sowohl mittels CD als auch I-124-PET/US untersucht wurden. Alle nuklearmedizinischen Ärzte aus Deutschland, Österreich und der Schweiz waren zur Teilnahme eingeladen. 106 Untersucher absolvierten jeweils 7,2 ± 1,8 (Median: 8, Bandbreite: 4–14) randomisiert zugewiesene digitale Patientenakten (CD oder CD+PET/US). Sie beurteilten die Funktion der Schilddrüsenknoten, ihre subjektive Sicherheit bei der Funktionsbeurteilung und schlugen einen Behandlungsverlauf vor.

Ergebnisse 68 digitale Patientenakten von 34 Patienten mit 66 Schilddrüsenknoten ≥ 1 cm (= 1,94 Knoten pro Patient) wurden erstellt. Insgesamt wurden 748 Bewertungen (11,2 pro Knoten) für CD und 751 Bewertungen (11,4 pro Knoten) für CD+PET/US dokumentiert. Bei CD+PET/US wurde die Funktion der Knoten im Vergleich zu CD häufiger als hyper- oder hypofunktionell (524 vs. 320; p < 0,0001) und seltener als indifferent oder nicht bewertbar (209 vs. 428; p < 0,0001) beurteilt. Die subjektive Sicherheit der Untersucher war bei CD+PET/US höher (p < 0,0001) und die Funktionsbeurteilungen wurden mit größerer Homogenität abgegeben (p < 0,0001). Bei CD+PET/US wurden im Vergleich zu CD weniger Verlaufskontrollen (p < 0,0001), mehr invasive Behandlungen (Feinnadelaspiration & Operation) (p < 0,0001), häufiger Radioiodtherapien (p = 0,0036) und seltener medikamentöse Therapien (p = 0,0167) empfohlen.

Schlussfolgerung Die Funktion von Schilddrüsenknoten wird in der konventionellen Diagnostik häufig falsch beurteilt. Der Anteil hyper- oder hypofunktioneller Läsionen wird unterschätzt. Die subjektive Sicherheit bei der Funktionsbeurteilung steigt durch den Einsatz der I-124-PET/US. Diese Ergebnisse beeinflussen die vorgeschlagenen Behandlungsverläufe.

Key words

thyroid nodules - iodine-124 - positron emission tomography - ultrasound - fusion imaging

Schlüsselwörter

Schilddrüsenknoten - I-124 - Positronenemissionstomografie - Ultraschall - Fusionsbildgebung

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