- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02545881
Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness (PROAG)
연구 개요
상세 설명
Prostate cancer is one of the most common neoplastic diseases in men. Prostate specific antigen (PSA) has only a limited role in the diagnosis and characterization of prostate cancer. The diagnosis of prostate cancer is still most commonly done by transrectal ultrasonography (TRUS) guided biopsy. However, TRUS guided biopsy carries a risk of increase in complications. There is an increasing interest in developing more accurate non-invasive imaging modalities which could potentially detect prostate cancer aggressiveness.
Diffusion weighted imaging (DWI) and rotating frame relaxation measurements have shown to be particularly promising in prostate cancer detection and characterization. This study which focuses on further development and validation of DWI and rotating frame relaxation measurements will enroll 200 men with histologically diagnosed prostate cancer who will undergo magnetic resonance imaging (MRI) before prostatectomy. Anatomical MRI and novel acquisition methods focusing on DWI and rotating frame relaxation measurements will be performed using surface coils to non-invasively detect and characterize prostate cancer.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Hannu Aronen, M.D., Ph.D.
- 전화번호: +358 2 3133896
- 이메일: hannu.aronen@utu.fi
연구 장소
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Turku, 핀란드, FI-20520
- 모병
- Department of Urology, Turku University Hospital
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연락하다:
- Peter Boström, M.D., Ph.D.
- 전화번호: +358 2 3130243
- 이메일: peter.bostrom@tyks.fi
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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:
- Age: 35 to 85 years
- Language spoken: Finnish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Diagnosis: Histologically confirmed adenocarcinoma of prostate
- No previous surgical, radiation or endocrine treatment for prostate carcinoma
- Clinical stage T1c-T3aN0 based on transrectal ultrasound, pelvic CT and bone scintigraphy
- Time period between the last biopsy and scheduled radical prostatectomy less than 8 months
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria:
- previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
- symptomatic acute prostatitis
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- uncontrolled serious infection
- claustrophobia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MR relaxation values
기간: Within 1 month prior to prostatectomy
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Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
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Within 1 month prior to prostatectomy
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MR DWI parameters
기간: Within 1 month prior to prostatectomy
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Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
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Within 1 month prior to prostatectomy
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Histological prostate cancer aggressiveness (Gleason grade)
기간: Within 1 month after MR imaging of the prostate
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Aim is to study the correlation between MRI parameters (MR relaxation values and different DWI parameters) and histological data including Gleason grade of prostate cancer
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Within 1 month after MR imaging of the prostate
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
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