- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07730203
Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM (PURE-CT/ANTHEM)
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body. If the urethra receives too much radiation, patients may experience urinary side effects.
Current CT scans used for treatment planning do not clearly show the urethra unless a urinary catheter is inserted. While a catheter can improve visibility, it may cause discomfort, increase the risk of infection, and slightly change the natural position of the urethra. MRI scans can also help visualize the urethra, but they are not always available and may not fit easily into all treatment workflows.
Photon-counting CT (PCCT) is a new type of CT scanner that produces higher-quality images with better detail. This technology may allow doctors to see the urethra without using a catheter.
The purpose of this pilot study is to investigate whether PCCT can reliably visualize the urethra in prostate cancer patients without the need for catheter insertion. If successful, this approach could make treatment planning more comfortable and less invasive while helping doctors better protect healthy tissues during radiotherapy.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ciro Franzese, MD, Radiation Oncologist
- 전화번호: +39 0282247454
- 이메일: ciro.franzese@hunimed.eu
연구 연락처 백업
- 이름: Laura Bonavita, Master degree
- 전화번호: +39 0282247026
- 이메일: laura.bonavita@humanitas.it
연구 장소
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Milan
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Rozzano, Milan, 이탈리아, 20089
- 모병
- Irccs Humanitas Research Hospital
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연락하다:
- Ciro Franzese, MD, Radiation Oncologist
- 전화번호: +39 0282247454
- 이메일: ciro.franzese@hunimed.eu
-
연락하다:
- Laura Bonavita, Master degree
- 전화번호: +39 0282247026
- 이메일: laura.bonavita@humanitas.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Prostate cancer candidate to radiotherapy
- Written informed consent.
- Eligibility for urethral catheter placement according to institutional practice
Exclusion Criteria:
- Active or suspected urinary tract infection.
- Known urethral stricture or recent urethral surgery
- Contraindication to catheter placement.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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quality of imaging
기간: Day of TC acquisition
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Quantitative quality of prostatic urethra contouring on non-catheter photon-counting CT, assessed using spatial overlap and boundary agreement metrics, specifically the Dice similarity coefficient (DSC) and the 95th percentile Hausdorff distance (HD95), with corresponding confidence intervals.
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Day of TC acquisition
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT
기간: immediately after TC acquisition
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Inter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).
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immediately after TC acquisition
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compare non-catheter urethral contours with catheter-based reference contours
기간: immediately after TC acquisition
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Agreement between non-catheter and catheter-based contours using spatial and geometric metrics (DSC and HD95).
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immediately after TC acquisition
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assess contouring confidence and contouring time across different PCCT reconstruction approaches
기간: immediately after TC acquisition
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Contour confidence score and contour time compared to standardized clinical times
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immediately after TC acquisition
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explore segmental urethral visualization along its anatomical course.
기간: immediately after TC acquisition
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evaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization
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immediately after TC acquisition
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Quantitative contour-derived parameters
기간: immediately after TC acquisition
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explore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility
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immediately after TC acquisition
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Willemink MJ, Persson M, Pourmorteza A, Pelc NJ, Fleischmann D. Photon-counting CT: Technical Principles and Clinical Prospects. Radiology. 2018 Nov;289(2):293-312. doi: 10.1148/radiol.2018172656. Epub 2018 Sep 4.
- Shah KD, Zhou J, Roper J, Dhabaan A, Al-Hallaq H, Pourmorteza A, Yang X. Photon-counting CT in cancer radiotherapy: technological advances and clinical benefits. Phys Med Biol. 2025 May 16;70(10):10TR01. doi: 10.1088/1361-6560/add4ba.
- Yoshimura T, Okubo K, Takase Y, et al. Visualizing the urethra by magnetic resonance imaging without catheterization: Post-urination MRI technique. European Journal of Radiology Open. 2021 Jul;8:100382
- Ong WL, Allan Hupman M, Davidson M, Ruschin M, Detsky J, Liu S, Vesprini D, Loblaw A. Urethra contouring on computed tomography urethrogram versus magnetic resonance imaging for stereotactic body radiotherapy in prostate cancer. Clin Transl Radiat Oncol. 2023 Dec 30;45:100722. doi: 10.1016/j.ctro.2023.100722. eCollection 2024 Mar.
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
- PURE-CT/ANTHEM
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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