- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03181425
Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment (TRACTILAGE)
Evaluation of Magnetic Resonance Imaging Diffusion Tensor and Knee Cartilage Tractography Reconstructions for the Study of Early Osteoarthritis
연구 개요
상태
정황
상세 설명
Knee osteoarthritis (OA) is a common and chronic degenerative disease of the articular cartilage. Despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration.
More and more studies report the benefits of Magnetic Resonance (MR) diffusion tensor imaging (DTI) in the study of early knee osteoarthritis and in particular the new MRI contrasts generating the Track Weighted Imaging (TWI) technique.
This observationnal, pilot, prospective, unrandomized and uncontrolled study aim to evaluate, for the first time, the new MRI tractography maps for the assessment of early knee osteoarthritis. This study doesn't modify the medical care of the patient.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Grenoble, 프랑스, 38043
- Orthopedic Surgery Department, University Hopital Grenoble Alpes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Over 18 years of age Knee prosthetic surgery indication with cartilage excision
Exclusion Criteria:
Refusal to sign a non-objection form
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Imaging assessment
All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision.
Imaging measurements are conducted on human cartilage samples (2 samples per patient are selected : healthy and severely degraded).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using the quantitative parameter of the average fiber lenght per voxel within a region of interest obtained from Average Pathlength Maps (APM).
기간: 6 months
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Correlation between the average fiber lenght per voxel within a region of interest (APM maps) obtained from MRI tractography reconstructions of human cartilage and the gold standard of the arthrosis grade(OARSI).
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.
기간: 6 months
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Correlation between the qualitative parameter of visual information (heterogeneity, contrast density by fiber density) and the gold standard of the arthrosis grade(OARSI).
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6 months
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Evaluation the of the MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) obtained from APM maps
기간: 6 months
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Correlation between the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) and the gold standard of arthrosis grade (OARSI).
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6 months
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Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.
기간: 6 months
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Correlation between the Track Weighted-Anisotropy Fraction (TW-FA) and the gold standard of arthrosis grade (OARSI).
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6 months
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Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.
기간: 6 months
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Correlation between the Track Weighted -Fibre Orientation Distribution (TW-FOD) and the gold standard of arthrosis grade (OARSI).
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6 months
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Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.
기간: 6 months
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Correlation between the Apparent Fibre Density (AFD) and the gold standard of arthrosis grade (OARSI).
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6 months
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Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.
기간: 6 months
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Correlation between the qualitative parameter from OCT and the gold standard of arthrosis grade (OARSI).
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6 months
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Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.
기간: 6 months
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Correlation between the quantitative parameters previously cited and the gold standard of arthrosis grade (OARSI) for each group of Anisotropy Fraction (FA).
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alexandre Moreau-Gaudry, MD, PhD, Clinical Investigation Centre for Innovative Technology Network, University Hopital, Grenoble
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- DCIC1614
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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