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

16 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400010

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Diagnostiskt test: 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.

Diagnostiskt test: 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.
Diagnostiskt test: 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.

Diagnostiskt test: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Extraocular Muscle SUVmax on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic Accuracy for Thyroid Eye Disease Activity
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Visual Positivity of Extraocular Muscle Uptake
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 november 2025

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

16 september 2026

Först inskickad som uppfyllde QC-kriterierna

16 september 2026

Första postat (Faktisk)

23 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2025480

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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