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Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease

16 septembre 2026 mis à jour par: Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Thyroid eye disease is an autoimmune disorder that can cause inflammation and fibrosis of the extraocular muscles and orbital tissues. Accurate assessment of disease activity is important for treatment planning, but commonly used clinical scores and conventional imaging each have limitations.

This prospective single-center cohort study will evaluate two molecular imaging approaches, gallium-68-labeled fibroblast activation protein inhibitor (68Ga-FAPI) PET/CT and PET/MR and gallium-68 DOTATATE somatostatin receptor PET/CT and PET/MR, in adults with thyroid eye disease and in a control group without thyroid-related or orbital disease. The study will compare visual and quantitative imaging findings, including maximum standardized uptake value and target-to-background ratio in the extraocular muscles, and examine their associations with clinical activity score and extraocular muscle thickness. The study aims to characterize the ability of these imaging methods, separately and in combination, to assess thyroid eye disease activity.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a prospective, single-center cohort study planned to enroll approximately 50 adults aged 18 to 75 years. The thyroid eye disease cohort will include approximately 30 participants diagnosed according to European Group on Graves' Orbitopathy criteria. The control cohort will include approximately 20 participants without a history of thyroid-related or orbital disease who undergo clinically indicated FAPI or somatostatin receptor PET imaging for another reason; orbital PET/MR acquisition will be added to the existing examination without additional radiation exposure.

Participants in the thyroid eye disease cohort will undergo 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MR imaging within one week. For each tracer, imaging will begin approximately 50 minutes after intravenous administration of 3 to 5 mCi. PET/CT will include a CT acquisition for attenuation correction and anatomic localization followed by three-dimensional PET acquisition of the head for approximately 5 minutes per bed position. PET/MR will include simultaneous PET acquisition and routine MR sequences, including T1-weighted, T2-weighted, and FLAIR imaging. PET images will be reconstructed using an ordered-subset expectation maximization algorithm and fused with CT or MR images.

Nuclear medicine physicians will evaluate images without access to clinical data. Each eye will be visually classified as positive when any extraocular muscle demonstrates uptake greater than background and negative otherwise. For participant-level analysis, a participant will be considered positive when at least one eye is positive. Quantitative analysis will measure maximum standardized uptake value in the superior, medial, lateral, and inferior rectus muscles. A 1-cm region of interest in occipital soft tissue will be used as background. The target-to-background ratio will be calculated as extraocular muscle SUVmax divided by background SUVmax.

Clinical information collected from electronic medical records will include age, sex, disease duration, clinical diagnosis, treatment plan, and Clinical Activity Score. Imaging measures will be compared between groups and modalities and will be examined for associations with Clinical Activity Score and extraocular muscle thickness. Receiver operating characteristic analysis will be used to evaluate diagnostic accuracy.

Type d'étude

Observationnel

Inscription (Estimé)

50

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Chine, 400010
        • Recrutement
        • Daping Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Participants will be selected from adults evaluated in the Department of Nuclear Medicine at the Army Medical Center of PLA between November 2025 and December 2027. The thyroid eye disease cohort will consist of patients meeting European Group on Graves' Orbitopathy diagnostic criteria. The control cohort will consist of patients without thyroid-related or orbital disease who undergo clinically indicated FAPI or somatostatin receptor PET imaging for another reason.

La description

Inclusion Criteria:

  • For the thyroid eye disease cohort: diagnosis of thyroid eye disease according to European Group on Graves' Orbitopathy criteria.
  • For the thyroid eye disease cohort: scheduled to undergo 68Ga-FAPI PET/CT and PET/MR and 68Ga-DOTATATE PET/CT and PET/MR within one week.
  • For the control cohort: clinically recommended to undergo FAPI or somatostatin receptor PET imaging for another reason, with no history of thyroid-related disease or orbital disease; orbital PET/MR is added to the existing examination without additional radiation exposure.

Exclusion Criteria:

  • Previous bilateral orbital surgery.
  • Treatment with glucocorticoids, monoclonal antibodies, or radiotherapy within the previous month.
  • Inability to remain supine.
  • Contraindication to MRI, including incompatible metallic implants or claustrophobia.
  • Planning pregnancy, currently pregnant, or breastfeeding.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Group 1 Thyroid Eye Disease Cohort

Adults diagnosed with thyroid eye disease according to European Group on Graves' Orbitopathy criteria. Participants undergo 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MR imaging within one week.
Test diagnostique: 68Ga-FAPI PET/CT and PET/MR Imaging

Participants receive 3 to 5 mCi of 68Ga-FAPI intravenously. PET/CT and PET/MR imaging of the head and orbits is performed approximately 50 minutes after injection, with PET acquisition of approximately 5 minutes per bed position. PET/MR includes routine T1-weighted, T2-weighted, and FLAIR sequences. The exact FAPI compound should be added if specified by the radiopharmacy documentation.

Required confirmation: the protocol does not identify the specific FAPI compound, such as FAPI-04.

Test diagnostique: 68Ga-DOTATATE PET/CT and PET/MR Imaging

Participants receive 3 to 5 mCi of 68Ga-DOTATATE intravenously. PET/CT and PET/MR imaging of the head and orbits is performed approximately 50 minutes after injection, with PET acquisition of approximately 5 minutes per bed position. PET/MR includes routine T1-weighted, T2-weighted, and FLAIR sequences.
Group 2 Control Cohort

Adults without a history of thyroid-related or orbital disease who undergo clinically indicated FAPI or somatostatin receptor PET imaging for another reason. Orbital PET/MR acquisition is added to the existing examination without additional radiation exposure.
Test diagnostique: 68Ga-FAPI PET/CT and PET/MR Imaging

Participants receive 3 to 5 mCi of 68Ga-FAPI intravenously. PET/CT and PET/MR imaging of the head and orbits is performed approximately 50 minutes after injection, with PET acquisition of approximately 5 minutes per bed position. PET/MR includes routine T1-weighted, T2-weighted, and FLAIR sequences. The exact FAPI compound should be added if specified by the radiopharmacy documentation.

Required confirmation: the protocol does not identify the specific FAPI compound, such as FAPI-04.

Test diagnostique: 68Ga-DOTATATE PET/CT and PET/MR Imaging

Participants receive 3 to 5 mCi of 68Ga-DOTATATE intravenously. PET/CT and PET/MR imaging of the head and orbits is performed approximately 50 minutes after injection, with PET acquisition of approximately 5 minutes per bed position. PET/MR includes routine T1-weighted, T2-weighted, and FLAIR sequences.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Extraocular Muscle SUVmax on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
Délai: At each imaging examination performed within the protocol-defined 1-week imaging period

Maximum standardized uptake value will be measured separately in the superior, medial, lateral, and inferior rectus muscles on PET/CT and PET/MR images for each tracer. Values will be summarized by tracer, imaging platform, eye, and participant group.
At each imaging examination performed within the protocol-defined 1-week imaging period
Extraocular Muscle Target-to-Background Ratio on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
Délai: At each imaging examination performed within the protocol-defined 1-week imaging period

For each extraocular muscle, target-to-background ratio will be calculated as extraocular muscle SUVmax divided by background SUVmax measured using a 1-cm region of interest in occipital soft tissue. Values will be summarized by tracer, imaging platform, eye, and participant group.
At each imaging examination performed within the protocol-defined 1-week imaging period

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Diagnostic Accuracy for Thyroid Eye Disease Activity
Délai: At completion of imaging and clinical activity assessment within the protocol-defined 1-week period

Receiver operating characteristic curves will be used to estimate the area under the curve for quantitative 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MR measures in relation to clinically defined thyroid eye disease activity.

Required confirmation: specify the reference standard and exact Clinical Activity Score threshold used to define active disease before submission.
At completion of imaging and clinical activity assessment within the protocol-defined 1-week period
Association Between PET Uptake Measures and Clinical Activity Score
Délai: At completion of imaging and Clinical Activity Score assessment within the protocol-defined 1-week period

Pearson correlation coefficients will be used to assess associations of extraocular muscle SUVmax and target-to-background ratio with Clinical Activity Score.
At completion of imaging and Clinical Activity Score assessment within the protocol-defined 1-week period
Association Between PET Uptake Measures and Extraocular Muscle Thickness
Délai: At each imaging examination performed within the protocol-defined 1-week imaging period

Pearson correlation coefficients will be used to assess associations of extraocular muscle SUVmax and target-to-background ratio with extraocular muscle thickness measured on anatomic imaging.

Required confirmation: specify the sequence, measurement plane, muscle-specific rule, and unit for extraocular muscle thickness.
At each imaging examination performed within the protocol-defined 1-week imaging period

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Visual Positivity of Extraocular Muscle Uptake
Délai: At each imaging examination performed within the protocol-defined 1-week imaging period

Each eye will be classified as positive when any extraocular muscle demonstrates 68Ga-FAPI or 68Ga-DOTATATE uptake greater than background and negative otherwise. At participant level, a participant will be classified as positive when at least one eye is positive. Positivity will be compared between imaging approaches using categorical analyses.
At each imaging examination performed within the protocol-defined 1-week imaging period

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 novembre 2025

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

16 septembre 2026

Première soumission répondant aux critères de contrôle qualité

16 septembre 2026

Première publication (Réel)

23 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025480

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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