갑상선암의 수술 전 평가에 AI 보조 초음파 기술의 임상 적용
2026년 8월 5일 업데이트: Bo Wang,MD, Fujian Medical University
본 연구는 갑상선암의 수술 전 평가에 AI 보조 초음파 기술의 적용을 탐구하는 것을 목표로 합니다.
갑상선암 환자의 전통적인 초음파 검사 데이터를 수집하고 AI 시스템을 활용해 갑상선 결절과 림프절을 발견하고 진단할 예정이다.
2차원 초음파와 AI 시스템 결과에 차이가 있을 경우 조직검사를 통해 추가 확인을 하게 된다.
이후 병리학적 결과는 AI 시스템과 기존 초음파 검사 결과를 비교하는 '최적 표준'이 되어 정확성과 신뢰성을 평가하게 됩니다.
이러한 연구 노력을 통해 갑상선암의 수술 전 평가를 위한 보다 정확하고 신뢰할 수 있는 방법이 제공되어 임상 의사 결정을 지원하고 의료 영상 진단 분야에서 AI의 새로운 적용을 위한 길을 열어줄 것입니다.
연구 개요
상태
완전한
상세 설명
본 연구는 갑상선암의 수술 전 평가에 AI 보조 초음파 기술의 적용을 조사하는 것을 목표로 합니다.
2차원 초음파 영상, 컬러 도플러 흐름 영상, 수, 크기, 형태, 에코 발생성, 경계, 석회화, 종횡비 등 갑상선 결절 및 림프절의 세부 특성을 포함한 갑상선암 환자의 전통적인 초음파 검사 데이터는 수집됩니다.
수술 전 AI 초음파 기술을 이용해 재평가를 진행하고, AI 시스템에 의한 갑상선 결절, 림프절 검출 및 진단 결과가 기록된다.
2차원 초음파 검사 결과와 AI 시스템 결과에 차이가 있는 경우에는 미세침 흡인 생검이나 수술 중 생검을 실시해 그 성질을 더 확인하게 된다.
수술 후 각 결절의 병리학적 결과는 AI 시스템과 기존 2차원 초음파 검사 간의 비교 분석을 위한 "최적 표준" 역할을 할 것입니다.
결절 검출 및 위치 파악에 있어 AI 시스템의 정확도를 분석하고, 민감도, 특이도, 정확도를 계산하여 갑상선암의 수술 전 평가에 대한 진단 유효성 및 신뢰성을 평가할 예정입니다.
본 연구를 통해 갑상선암의 수술 전 평가를 위한 보다 정확하고 신뢰성 있는 보조 진단법을 제공하여 임상적 의사결정에 도움을 주고자 합니다.
또한, 의료 영상 진단 분야에서 AI를 적용하기 위한 새로운 길과 방향을 모색할 것입니다.
연구 유형
중재적
등록 (실제)
515
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Fujian
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Fuzhou, Fujian, 중국, 350001
- Fujian Medical University Union Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 수술 전 갑상선 악성종양의 병리학적 확인이 되어 수술적 치료를 받고 있는 환자.
- 갑상선 선종 등 압박 증상을 유발하는 양성 갑상선종양으로 수술적 치료를 받고 있는 환자.
- 완전하고 고품질의 전통적인 2차원 컬러 초음파 이미지를 가진 환자.
- 수술 후 병리학 보고서를 작성하세요.
- 본 임상시험에 참여하려는 의지와 사전 동의서에 서명합니다.
제외 기준:
- 목 수술이나 방사선 치료의 병력이 있는 환자.
- 신체의 다른 부위에 악성 종양의 병력이 있는 환자.
- 갑상선 기능 장애가 있는 환자.
- 불완전하거나 품질이 낮은 기존의 2차원 컬러 초음파 이미지.
- 불완전한 수술 후 병리학 보고서.
- 본 임상시험 참여를 거부합니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: AI-Assisted Preoperative Review
Participants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output.
The AI system does not assess cervical lymph nodes.
All supplementary examinations and final diagnostic and surgical decisions are made by clinicians.
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After standard preoperative ultrasonography, the same participant underwent a standardized AI-assisted repeat examination.
The locked system identified and classified thyroid nodules and provided malignancy-score information for surgeon-led review.
It did not assess cervical lymph nodes and was not retrained or recalibrated during the study.
Additional fine-needle aspiration, intraoperative pathologic examination, and surgical management were determined by clinicians using the complete clinical assessment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
기간: From completion of the AI-assisted repeat examination through completion of surgery
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Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery.
Each participant is counted once regardless of the number of examinations.
The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
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From completion of the AI-assisted repeat examination through completion of surgery
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Proportion of Participants With a Change in Planned Surgical Management
기간: From completion of the AI-assisted review through surgery
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Number and proportion of enrolled participants with at least one documented change in the surgeon-led planned surgical approach or extent after conventional ultrasonography, AI-assisted review, and any supplementary pathological examination, when performed.
Changes may involve thyroid resection or cervical lymph-node management.
Each participant is counted once regardless of the number of changes.
The AI system provided thyroid-nodule information only and did not assess cervical lymph nodes.
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From completion of the AI-assisted review through surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules
기간: During standard preoperative ultrasonography, before the AI-assisted repeat examination
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Number and percentage of evaluated thyroid nodules in each clinician-assigned C-TIRADS category during conventional ultrasonography.
Nodule size, composition, echogenicity, margins, calcifications, and clinician-assessed cervical lymph-node findings were recorded as descriptive covariates and were not treated as separate outcome measures.
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During standard preoperative ultrasonography, before the AI-assisted repeat examination
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Proportion of Evaluated Thyroid Nodules Classified as AI-Positive
기간: During the preoperative AI-assisted repeat examination, before surgery
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Number and percentage of evaluated thyroid nodules with a locked AI malignancy score >0.5.
The AI system evaluated thyroid nodules only and did not assess cervical lymph nodes.
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During the preoperative AI-assisted repeat examination, before surgery
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Results of Supplementary Cytologic or Pathologic Examinations
기간: From supplementary sampling to availability of the corresponding result, before or during surgery
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Among participants who underwent at least one additional cytologic or pathologic examination, record the cytologic or histopathologic result for each sampled thyroid nodule or cervical lymph node.
Results are summarized at the examination level as nonmalignant, indeterminate, malignant, or metastatic, as applicable.
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From supplementary sampling to availability of the corresponding result, before or during surgery
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Final Histopathological Diagnosis of Resected Thyroid Nodules
기간: From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each resected thyroid nodule linked unambiguously to the evaluated lesion, record the final diagnosis as benign, malignant, follicular tumor of uncertain malignant potential (FT-UMP), well-differentiated tumor of uncertain malignant potential (WDT-UMP), non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), or another borderline diagnosis.
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From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Sensitivity of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, sensitivity is TP/(TP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
These lesion-level exclusions do not alter the 515-participant workflow cohort.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level False-Negative Rate of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each method, the false-negative rate is FN/(TP + FN), expressed as a percentage, among definitively malignant thyroid nodules.
AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Positive Predictive Value of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each method, positive predictive value is TP/(TP + FP), expressed as a percentage, among thyroid nodules classified as positive.
AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Youden Index of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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For each method, the Youden index is sensitivity + specificity - 1 using fixed binary thresholds.
AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Distribution of Cervical Lymph-Node Metastasis Status Among Pathologically Examined Nodes
기간: From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Among cervical lymph nodes actually removed or sampled and pathologically examined, record the number and percentage with and without metastasis.
No pathologic reference diagnosis is assigned to unsampled lymph nodes.
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From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Specificity of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, specificity is TN/(TN + FP), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
|
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
|
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Nodule-Level Negative Predictive Value of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, negative predictive value is TN/(TN + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
|
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Nodule-Level Accuracy of AI and C-TIRADS
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, accuracy is (TP + TN)/(TP + TN + FP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher).
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Area Under the ROC Curve for the Continuous AI Malignancy Score
기간: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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Using definitive postoperative histopathology as the reference standard, calculate the area under the receiver operating characteristic curve for the continuous locked AI malignancy score.
Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis.
Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
No AUC is calculated for the single-threshold C-TIRADS classification.
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From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 9월 1일
기본 완료 (실제)
2025년 9월 28일
연구 완료 (실제)
2025년 10월 15일
연구 등록 날짜
최초 제출
2024년 6월 9일
QC 기준을 충족하는 최초 제출
2024년 7월 11일
처음 게시됨 (실제)
2024년 7월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 5일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AI-base PCD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data are not planned for external sharing because the dataset contains detailed clinical records and ultrasound images that may remain re-identifiable, and the available study records do not document participant consent specifically permitting external IPD sharing or institutional authorization for such sharing.
Aggregate, non-identifiable results will be reported in publications.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .