DLSCT for Breast Cancer Detection in Women With Dense Breasts (DECREAS)
Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
연구 개요
상태
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Carla M Meeuwis, MD,PhD
- 전화번호: +31 26 378 8888
- 이메일: cmeeuwis@rijnstate.nl
연구 장소
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Arnhem, 네덜란드
- 모병
- Rijnstate Hospital
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연락하다:
- Carla A Meeuwis, MD, PhD
- 이메일: cmeeuwis@rijnstate.nl
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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:
Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
- Tumors > 5 cm (= T3) or
- Tumors with invasion of the skin or chest wall (= T4) or
- Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
- Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Exclusion Criteria:
- History of allergic reactions to iodinated contrast agents
- Pregnancy or breast feeding
- Treatment of thyroid disease with radioactive iodine
- Use of metformin
- Creatinine clearance < 45 ml/min
- Chronic or acutely worsening renal disease
- Patients who are declared incompetent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual tumor conspicuity
기간: On the same 1 day as the regular PET-CT scan was performed
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The conspicuity of tumors will be graded on a 4-point confidence scale
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On the same 1 day as the regular PET-CT scan was performed
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BI-RADS score
기간: On the same 1 day as the regular PET-CT scan was performed
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BI-RADS score according to the ACR BI-RADS lexicon
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On the same 1 day as the regular PET-CT scan was performed
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Iodine enhancement
기간: On the same 1 day as the regular PET-CT scan was performed
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Iodine enhancement will be measured in Hounsfield Units (HU).
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On the same 1 day as the regular PET-CT scan was performed
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Iodine content
기간: On the same 1 day as the regular PET-CT scan was performed
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Iodine content will be measured mg/mL.
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On the same 1 day as the regular PET-CT scan was performed
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laura N Deden, Rijnstate Hospital
- 수석 연구원: Maxime V.P. Schyns, MD, Rijnstate Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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. .