- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03051802
Feasibility Study of Navigated Endoscopy for the Placement of High Dose Rate Brachytherapy Applicators in the Esophagus and Lung
연구 개요
상세 설명
High dose rate brachytherapy is used in a limited number of esophagus and lung patients, often in combination with external beam radiation therapy. The procedure uses an applicator inserted into the lumen with the applicator connected to an automated "afterloader", a device with a radioactive brachytherapy source attached to a thick guide wire that positions the source within the applicator at set positions and times based on a treatment plan. Identification of the ideal applicator position is determined by white light endoscopy. With the endoscope in the lumen, fluoroscopic imaging can visualize the endoscope position. Temporary radio-opaque skin markers are placed on the patient's anterior surface under fluoroscopy imaging so that they align with the endoscope tip. The proximal and the distal ends of the target volume are marked in this manner by the surgeon stopping the endoscope at these positions. The endoscope is removed and the applicator inserted, with the positions of the applicator and "dummy" seeds (i.e. non-radioactive seeds used only for positioning purposes) aligned under fluoroscopy to match the skin markers. The procedure has 2 disadvantages: i. There is extra radiation dose to the clinical staff due to the fluoroscopy used to identify the source position.
ii. Visualization is only in 2D, which is inaccurate since it does not account for separations in the vertical direction and the angle of projection between the applicator and the so patient surface. Furthermore, any movement of the fluoroscopy device during the insertion leads to errors in visualization.
Medical applications of navigated endoscopy continue to grow, especially when used in combination with volumetricimaging for image-guided procedures. This feasibility study is aimed to use navigation endoscopy technology to overcome the disadvantages of the current practice and improve the overall process.
In the proposed protocol, applicator insertion, tracking and recording of the endoscope and applicator positions would enable placement of the applicator using 3D information, with greater accuracy and without extra radiation dose to the clinical staff. The tracking technology would be used to replace the use of radio-opaque skin markers; rather than placing these markers on the patient's skin, the location of the target volume boundaries would be noted by the tracker position within the endoscope. Applicator insertion would also be tracked, with the applicator positioning based on the location of the applicator relative to the previously recorded endoscope positions, including the locations of the distal and proximal ends of the target volume.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 18 years
- Primary or metastatic cancer including endoluminal disease of either the lung or the esophagus
- Intention to treat using high dose rate brachytherapy as part of standard radiotherapy.
- Ability to provide written informed consent to participate in the study
Exclusion Criteria:
- Contraindications to standard radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness
- Concurrent illness or condition that precludes subject from undergoing endoscopy
- Patient is unable to tolerate an hour and a half long procedure. Standard of care practice is no more than 1 hour. However, with the additional tracking component, the procedure could be at most 1.5 hours long.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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proportion of navigated endoscopy procedures that were successfully completed
기간: 18 months
|
To assess clinical feasibility of inserting intraluminal (esophagus or lung) HDR applicators using navigation technologies for tracking endoscope and applicator insertion. This study is designed to assess the workflow when using the EM tracking technology and the accuracy of the procedure will be measured by comparison with current standard of care. |
18 months
|
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Positional accuracy
기간: day 1
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To compare the positional accuracy of the navigation procedure versus the current standard of care using 2D fluoroscopy using analysis of tracking data.
All tracking data will be recorded for post-procedure analysis and comparison with the fluoroscopic imaging performed during current standard of care
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day 1
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Optimize the clinical protocol using this technology
기간: 6 months
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The procedure will be assessed in detail (based on time and workflow) after three patients.
Participants in the review of the procedure will include surgeon, radiation oncologist, brachy-therapists and physicists.
Workflow improvements will be implemented at this time.
|
6 months
|
공동 작업자 및 조사자
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 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. .