Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Xiao Chen, PH .D
- 전화번호: 15922970174
- 이메일: xiaochen229@tmmu.edu.cn
연구 장소
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400010
- 모병
- Daping Hospital
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연락하다:
- Xiao Chen, PH.D
- 전화번호: 15922970174
- 이메일: xiaochen229@tmmu.edu.cn
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
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. 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. |
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. 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Extraocular Muscle SUVmax on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic Accuracy for Thyroid Eye Disease Activity
기간: 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
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Association Between PET Uptake Measures and Clinical Activity Score
기간: At completion of imaging and Clinical Activity Score assessment within the protocol-defined 1-week period
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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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual Positivity of Extraocular Muscle Uptake
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025480
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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