- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07925125
Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions
Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis, and early detection of pancreatic lesions is of great importance for improving patient outcomes. In this study, whole-body imaging with FDG and FAPI will be used to visualize the early development of pancreatic cancer lesions from multiple perspectives, including glucose metabolism, tumor fibrotic stroma, and integrin receptor expression. Furthermore, leveraging the advantages of four-dimensional dynamic long-axial PET imaging, artificial intelligence-assisted lesion detection and analysis will be performed to characterize lesions and differentiate between benign and malignant lesions. The imaging findings will subsequently be compared with postoperative histopathological results to evaluate the diagnostic performance of the proposed imaging approaches.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Li
- 전화번호: 0086-021-64370045
- 이메일: lb10363@rjh.com.cn
연구 장소
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Shanghai, 중국, 200025
- 모병
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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연락하다:
- Li
- 전화번호: 0086-021-64370045
- 이메일: lb10363@rjh.com.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with suspected pancreatic tumors treated at Ruijin Hospital
설명
Inclusion Criteria:
- Patients with suspected pancreatic tumors larger than 1.0 cm.
- No histopathological diagnosis available before enrollment.
- No prior treatment for the suspected pancreatic tumor.
- Histopathological diagnosis obtained through surgery or biopsy within 2 months after PET imaging.
- Able and willing to provide written informed consent.
- Willing and able to comply with the study procedures and follow-up requirements.
- Male or female, aged 18-75 years.
- In generally good health, with an estimated life expectancy of more than 6 months and able to tolerate the imaging procedures.
Exclusion Criteria:
- Severe concomitant diseases that, in the investigator's judgment, make participation in the study inappropriate, including severe cardiopulmonary dysfunction or severe hepatic or renal impairment.
- Pregnancy, suspected pregnancy, or breastfeeding.
- Poor compliance with the study procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients with Suspected Pancreatic Lesions
Participants with suspected pancreatic lesions undergoing PET imaging will be enrolled in this prospective observational study. Imaging approaches may include FDG and FAPI PET, with four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted lesion detection and characterization. Imaging findings will be evaluated for lesion detection and benign-malignant differentiation and compared with postoperative histopathological results when available. |
Routine PET imaging performed as part of clinical care will be evaluated in this prospective observational study. Four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted image analysis will be used for pancreatic lesion detection and characterization, including differentiation between benign and malignant lesions. Imaging findings will be compared with histopathological results when available. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization
기간: Within 2 months after PET imaging
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The diagnostic performance of 4D dynamic long-axial PET imaging combined with artificial intelligence-assisted lesion detection and analysis will be evaluated for the detection and differentiation of benign and malignant pancreatic lesions. Imaging findings will be compared with postoperative histopathological results as the reference standard |
Within 2 months after PET imaging
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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
- RuijinH 2024(338)
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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