- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02331381
Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device
A Pilot Study of Imaging and Plan Workflow in a Novel Low-Field Magnetic Resonance Imaging (MRI) Radiotherapy Device
연구 개요
상세 설명
Recently, Viewray Inc (Cleveland, OH) has released the RenaissanceTM System 1000, which consists of the combination of an open, split solenoid 0.35 T MRI scanner that is equipped for parallel imaging with a 60Co gamma-ray radiation treatment unit. The MRI scanner is required to be a low field unit to allow for imaging with spatial integrity by limiting magnetic susceptibility artifacts due to the patient and to prevent significant perturbations of the dose distribution. The 0.35 T magnet is a variant of the Siemens MAGNETOM product used for intraoperative imaging.
A previous study of pilot imaging using this device without the 60Co sources was completed in 2012 (HRPO# 201105295). In this study, a total of 26 patients were imaged with the device. Fourteen of these patients also had onboard CT imaging (OB-CT) where the two sets of imaging and relative organs at risk (OARs) could be compared. Fifteen to 24 OARs were evaluated per anatomical site. In total, 221 OARs and 10 target structures were compared for visualization on MRI and OB-CT image sets by each physician. At least 2/3 physicians evaluated MRI as offering better visualization for 71% of structures, OB-CT offering better visualization for 10% of structures, and both offering equivalent visualization for 14% of structures. Physicians agreed unanimously for 74% and in majority for >99% of structures evaluated, respectively. For <1% of structures, no consensus was reached. Targets were better visualized on MRI in 4/10 cases, and were never better visualized on OB-CT images.
There were limitations to this prior study. The patients were not imaged in immobilization devices that are commonly used in radiation therapy. This precluded the creation of a mock radiation therapy plan using the device for these patients. Also, the device was not evaluated in the context of radiation therapy decision making, such as patient shifts, target localization and patient repositioning.
The purpose of this study is to evaluate the imaging and plan workflow for radiation therapy utilizing this novel device. For this protocol, only the MRI scanner of the machine will be utilized. The 60Co portion of the machine capable of radiation treatment administration will not be utilized, and there will be no experimental treatments or modifications to each patient's standard of care radiation treatment plan.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Missouri
-
St. Louis, Missouri, 미국, 63110
- Washington University School of Medicine
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Eligibility Criteria:
- Scheduled to receive radiation therapy.
- At least 18 years of age.
- Does not meet any standard contraindications for MRI (such as being claustrophobic, having metal objects within the body that cannot be removed or having large tattoos), confirmed by completion of our clinical MRI questionnaire form
- Able to understand and willing to sign an IRB approved written informed consent document.
공부 계획
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 |
---|---|
실험적: MRI
Participants will have a custom immobilization device created for them for the purpose of the study.
They will be scanned from one to four occasions during radiation treatment.
If enrolled in the study prior to the first radiation treatment, the first imaging scan may be scheduled prior to the first radiation treatment, with subsequent scans during treatment separated by at least one day.
Patients will be in the scanner for approximately 30 minutes to one hour, either prior to or following their standard of care radiotherapy treatment.
|
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adequacy of the radiation therapy plan
기간: Duration of radiation therapy
|
The radiation plan will be evaluated based on the recorded clinical goals prescribed by the attending physician.
Plans will be classified as 'adequate' if they meet the prescribed goals for the clinical radiation therapy plan.
|
Duration of radiation therapy
|
Feasibility of patient localization workflow
기간: Duration of radiation therapy
|
The localization time will be classified as 'adequate' if it is less than or equal to 15 minutes.
|
Duration of radiation therapy
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jeff Michalski, M.D., Washington University School of Medicine
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 (추정)
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
- 201311081
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
미국에서 제조되어 미국에서 수출되는 제품
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. .
암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)모집하지 않고 적극적으로III기 전립선 선암종 AJCC v7 | II기 전립선 선암종 AJCC v7 | 1기 전립선 선암종 American Joint Committee on Cancer(AJCC) v7미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
자기 공명 영상에 대한 임상 시험
-
University of Wisconsin, MadisonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford University모병
-
University Hospital, Bordeaux완전한
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR); McGill University Health Centre/Research... 그리고 다른 협력자들모병
-
Biotronik SE & Co. KG완전한심장병독일, 체코 공화국, 스위스, 오스트리아, 영국
-
Shanghai Ninth People's Hospital Affiliated to...모병
-
French Cardiology SocietyInstitut National de la Santé Et de la Recherche Médicale, France완전한