- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03000751
CT DOS 협업
2024년 3월 5일 업데이트: University of California, San Francisco
CT 선량 최적화 및 표준화 노력(DOSE) 협력
이것은 다양한 의료 전달 시스템에서 방사선 선량 데이터를 풀링하여 진단 CT에 사용되는 선량의 변화를 탐색하기 위한 실용적인 계단식 웨지 클러스터 무작위 통제 시험입니다.
선량을 낮추고 최적화하기 위한 다양한 전략을 비교하고 성공적인 선량 최적화 전략을 구현하고 관행을 표준화하는 데 장애물과 촉진제를 식별합니다.
연구 개요
상세 설명
조사관은 계단식 웨지 클러스터 무작위 통제 시험을 사용하여 모든 협력 의료 시설에서 CT에 대한 방사선 선량 정보를 수집하고 시설 전체에서 선량을 최적화하기 위해 여러 가지 개입을 주도하고 있습니다. CT 방사선 선량 데이터를 수집하고 이 결과를 사용하여 협력 의료 시설에 피드백을 제공하는 것 외에도 각 현장에서 수석 방사선 전문의, 기술자 및 의학 물리학자와 같은 주요 정보원을 포함하여 여러 개인에 대한 설문 조사를 수행할 것입니다. , 방사선과 관리자.
선량 최적화의 성공 및 실패와 관련된 촉진제 및 장벽(참여 시설에 대한 설문 조사를 통해 평가됨)을 비교하고 식별합니다.
연구 유형
중재적
등록 (실제)
864080
단계
- 해당 없음
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
99년 이하 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 연구 기간 내에 수행된 머리, 가슴 및/또는 복부/골반의 진단적 CT 스캔
제외 기준:
- 머리, 가슴 및/또는 복부/골반이 아닌 비진단 스캔
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 트랙 A
단순 감사 보고서; 대면 회의(다중 구성 요소 개입과 일치하는 시간) 다중 구성 요소 개입
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간단한 감사는 방사선량에 대한 비교 및 피드백을 제공합니다.
다중 구성 요소 개입은 필요한 변화에 대한 맞춤형 피드백과 조직 변화를 촉진하는 품질 개선 방법을 사용하는 지침을 제공합니다.
전문가, 세부 감사, 협업 통화 및 현장 방문(필요한 경우)에 대한 액세스를 제공합니다.
품질 향상에 중점을 둔 협력자 회의.
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활성 비교기: 트랙 B
대면 회의(간단한 감사 보고서와 일치하는 시간) 단순 감사 보고서; 다중 구성 요소 개입
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간단한 감사는 방사선량에 대한 비교 및 피드백을 제공합니다.
다중 구성 요소 개입은 필요한 변화에 대한 맞춤형 피드백과 조직 변화를 촉진하는 품질 개선 방법을 사용하는 지침을 제공합니다.
전문가, 세부 감사, 협업 통화 및 현장 방문(필요한 경우)에 대한 액세스를 제공합니다.
품질 향상에 중점을 둔 협력자 회의.
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다른: 트랙 C
단순 감사 보고서; 다중 구성 요소 개입
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간단한 감사는 방사선량에 대한 비교 및 피드백을 제공합니다.
다중 구성 요소 개입은 필요한 변화에 대한 맞춤형 피드백과 조직 변화를 촉진하는 품질 개선 방법을 사용하는 지침을 제공합니다.
전문가, 세부 감사, 협업 통화 및 현장 방문(필요한 경우)에 대한 액세스를 제공합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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평균유효선량(ED)의 변화
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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감사 및 다중 구성 요소 개입 전과 비교하여 단순 감사 및 다중 구성 요소 개입(MCI) 후 평균 유효 선량의 변화를 평가할 것입니다.
아래에 제공된 숫자는 기준 기간에 비해 평균 선량(밀리시버트 단위)의 절대 변화를 반영합니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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벤치마크보다 유효선량이 높은 CT 스캔의 비율
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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감사 전 선량과 MCI 전 선량과 비교하여 단순 감사 후와 다성분 중재(MCI) 후 유효 선량이 벤치마크보다 높은 검사 비율의 변화를 평가할 것입니다.
각 해부학적 영역에 대한 벤치마크는 개입 전(기준선) 기간 동안 선량 분포의 75번째 백분위수로 정의됩니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
평균 투여량 길이 제품
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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감사 및 MCI 전과 비교하여 감사 및 MCI 후 용량 길이 제품의 변화를 평가할 것입니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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벤치마크보다 높은 선량 길이 제품을 사용한 CT 스캔의 비율
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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우리는 감사 전 선량 및 MCI와 비교하여 감사 후 및 MCI 후 기준치를 초과하는 선량 길이 제품을 사용한 검사 비율의 변화를 평가할 것입니다.
각 해부학적 영역에 대한 벤치마크는 개입 전 기간 동안 선량 분포의 75번째 백분위수로 정의됩니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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평균 부피 컴퓨터 단층촬영 선량 지수(CTDIvol)의 변화
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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감사 및 MCI 중재 전과 후의 평균 CT 선량 지수(CTDIvol) 변화를 평가할 것입니다.
CTDIvol(밀리그레이 단위, mGy)은 스캐너에 의해 CT 슬라이스당 전달되는 방사선량을 반영하는 방사선량의 척도입니다.
CTDIvol이 높을수록 방사선량이 더 많다는 의미입니다.
일반적으로 CTDIvol의 감소는 환자의 과도한 방사선 노출을 최소화하는 품질 개선의 신호입니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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벤치마크보다 CTDIvol이 높은 CT 스캔의 비율
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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우리는 감사 및 다성분 중재 전 선량과 비교하여 감사 후 및 다성분 중재 후 CTDIvol이 벤치마크보다 높은 검사 비율의 변화를 평가할 것입니다.
각 해부학적 영역에 대한 벤치마크는 개입 전 기간 동안 선량 분포의 75번째 백분위수로 정의됩니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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평균 장기 선량의 변화: 머리 CT의 뇌 선량; 흉부 CT의 폐선량; 복부 CT에 대한 결장 및 간 선량
기간: 사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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감사 및 다성분 중재 전과 비교하여 단순 감사 및 다성분 중재(MCI) 후 장기 선량의 변화를 평가할 것입니다.
아래에 제공된 숫자는 기준 기간에 비해 평균 선량(밀리시버트 단위)의 절대 변화를 반영합니다.
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사이트는 개입 시기를 결정하는 3개 트랙 중 1개 트랙으로 무작위 배정되었습니다. 트랙 A: 40주차 감사, 68주차 MCI 트랙 B: 44주차 감사, 74주차 MCI 트랙 C: 53주차 감사, 68주차 MCI 81주차
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Rebecca Smith-Bindman, MD, University of California, San Francisco
- 수석 연구원: Judy Yee, MD, San Francisco Veterans Administration
- 수석 연구원: Tom Nelson, PhD, University of California, San Diego
- 수석 연구원: Tony Seibert, PhD, University of California, Davis
- 수석 연구원: Mayil Krishnam, MD, University of California, Irvine
- 수석 연구원: Michael Flynn, PhD, Henry Ford Health System
- 수석 연구원: Mary Cocker, MSc, Csci, Oxford University Hospitals NHS Trust
- 수석 연구원: William Boswell, MD, City of Hope Medical Center
- 수석 연구원: Sebastian Schindera, MD, University Hospital of Basel
- 수석 연구원: Erin Bell, MHP, Community Health Network
- 수석 연구원: Phuong-Anh Duong, MD, Emory University
- 수석 연구원: Nima Kasraie, PhD, MSc, Children's Mercy Hospital Kansas City
- 수석 연구원: Pavlina Pike, PhD, Huntsville Hospital
- 수석 연구원: Luisa Cervantes, MD, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- 수석 연구원: Joachim Wildberger, PhD, Maastricht University Medical Center
- 수석 연구원: Michael Forsting, MD, University of Duisburg-Essen
- 수석 연구원: Fady Kassem, PhD, St. Joseph Hospital of Orange
- 수석 연구원: Darrell Fendrick, CT, East Texas Medical Center
- 수석 연구원: Sugoto Mukherjee, MD, University of Virginia Health System
- 수석 연구원: Brad Delman, MD, Icahn School of Medicine at Mount Sinai
- 수석 연구원: Jodi Roehm, Center For Diagnostic Imaging
- 수석 연구원: Anokh Pahwa, MD, Olive View - UCLA
- 수석 연구원: Ryan Lee, MD, MBA, Einstein Medical Center
- 수석 연구원: Jay Starkey, MD, St. Luke's International Hospital, Tokyo
- 수석 연구원: Diana Miglioretti, PhD, University of California, Davis
- 수석 연구원: Saravanabavaan Suntharalingam, MD, University of Duisburg-Essen
- 수석 연구원: Sara Lewis, MD, Icahn School of Medicine at Mount Sinai
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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2016년 7월 1일
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2016년 12월 19일
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