- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01956409
Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis
Use of Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis, Prediction of Clinical Outcome and Monitoring of Treatment Response to Neoadjuvant Chemotherapy
The application of FCH PET in breast cancer diagnosis has not been reported.
We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the similar pathophysiological mechanism to choline on proton MRS, and our study goals are:
- To investigate and compare the diagnostic performance of proton MRS and FCH PET for localized findings on mammography and breast ultrasound.
- To investigate whether FCH PET findings are correlated with choline signals on proton MRS.
- To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated with factors related to clinical outcome and prognosis- that is, molecular markers, tumor staging, histologic grade of breast cancers.
- For localized advanced breast cancer, to investigate the treatment response to NAC using proton MRS and FCH PET, and to evaluate which modality is more sensitive.
- To investigate the usefulness of FCH PET for whole body staging for breast cancer patients.
연구 개요
상세 설명
In recent years, the application of 18F-FDG PET (positron emission tomography) and MRI for breast lesion diagnosis was emerging. Imbriaco et al compared the diagnostic performance of 18F-FDG PET and MRI for suspicious breast lesions, with PET showing a sensitivity of 80% and specificity 100%; and MRI revealed a sensitivity of 95% and specificity of 98%. Lim et al studied 18F-FDG PET-CT with MRI to monitor treatment response for breast cancer patients receiving NAC, with a sensitivity 70% and specificity 72%, and can detect the treatment response earlier than conventional imaging.
However, 18F-FDG is not tumor specific, and searching for an alternative tracer agent as a tumor biomarker is necessary. 18F-Fluorocholine (FCH), a choline analog, was used for diagnosis of prostate cancer, hepatocellular carcinoma (HCC), bronchioloalveolar carcinoma, brain tumor, since malignant tumors show higher choline metabolites than benign lesions; it was reported that FCH PET showed higher sensitivity (88-94%) than 18F-FDG PET (59-68%) in detecting HCC. FCH PET was used for staging for prostate cancer, with FCH PET-CT can provide sufficient information for management with an accuracy of 88%.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Taipei, 대만, 100
- National Taiwan University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women aged 20-75 years old.
- with localized findings on mammography or breast ultrasound in recent 3 months and who will receive breast biopsy or excision for the findings; or with recently diagnosed LABC who will receive NAC.
Exclusion Criteria:
- unable to cooperate with the examinations
- pregnant or planning to be pregnant
- estimated GFR (eGFR) < 60 ml/min/1.73m2 or with recent acute renal failure, past history of renal dialysis.
- Past history of claustrophobia
- Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.
- with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (<2 months).
- Past history of breast cancer or other malignancy (treated within 5 years).
- lactating.
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 |
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실험적: diagnostic accuracy of PET and MR spectroscopy
To investigate the diagnostic accuracy of 18F-Fluorocholine PET and proton MR spectroscopy of breast lesions, using pathology as gold standard.
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다른 이름들:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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diagnostic accuracy of 18F-FCH PET for breast cancer diagnosis
기간: 5 years
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The investigators use the interpretation results of 18F-FCH PET for breast lesion diagnosis, with the pathology result of the breast lesions as gold standards, and to investigate how well the 18F-FCH PET can correctly diagnose the true nature of breast lesions.
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5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Monitoring of treatment response of breast cancer to chemotherapy using 18F-FCH PET
기간: 5 years
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For the breast cancer patients who will undergo chemotherapy treatment, we aim to use 18F-FCH PET before and after chemotherapy.
And the changes of tracer uptake of 18F-FCH on PET scans before and after chemotherapy will be correlated with clinical outcomes before and after chemotherapy, to investigate whether 18F-FCH PET results can monitor treatment response of chemotherapy.
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5 years
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diagnostic accuracy of breast MR spectroscopy for breast cancer diagnosis
기간: 5 years
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The investigators use the interpretation results of breast MRI (with MR spectroscopy in the examination) for breast lesion diagnosis, with the pathology result of the breast lesions as gold standards, and to investigate how well the breast MRI study can correctly diagnose the true nature of breast lesions.
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5 years
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기타 결과 측정
결과 측정 |
기간 |
---|---|
Evaluation the correlation of 18F-FCH PET and breast MRI
기간: 5 years
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5 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 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. .
자기 공명 영상에 대한 임상 시험
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Biotronik SE & Co. KG완전한
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Biotronik SE & Co. KG완전한MR(Magnetic Resonance) 조건부 CRT 심장박동기 및 ICD의 안전성프랑스, 독일, 헝가리, 캐나다, 호주, 오스트리아, 체코 공화국, 스위스
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Samsung Medical Center모집하지 않고 적극적으로
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
18F-FCH에 대한 임상 시험
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Sir Mortimer B. Davis - Jewish General Hospital완전한
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)완전한
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Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR)완전한
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Sir Mortimer B. Davis - Jewish General Hospital완전한
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University Health Network, TorontoProstate Cancer Canada완전한
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Queen's Medical CenterNational Cancer Institute (NCI)모병
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La Jolla Pharmaceutical Company완전한자가면역질환 | 전신성 홍반성 루푸스 | 루푸스 신염 | 면역 질환 | 루푸스 사구체신염미국, 오스트리아, 캐나다, 프랑스, 독일, 이탈리아, 멕시코, 스페인, 스웨덴, 영국
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Imperial College LondonMedical Research Council; ECMC모병
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Central Hospital, Nancy, FranceGIE NANCYCLOTEP; Advanced Nuclear Medicine Ingredients (ANMI)알려지지 않은