Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI
Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen
Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.
This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.
연구 개요
연구 유형
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI within 1 year prior to starting tamoxifen
- Premenopausal status is defined as intact ovaries and still menstruating
- Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility
- Willing and able to undergo all study procedures
Exclusion Criteria:
- Contraindication to breast MRI (such as non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium)
- Bilateral breast cancer or treatment such as:
- History of or planned bilateral breast irradiation
- History of or planned bilateral mastectomy
- Bilateral breast cancer
- History of unilateral mastectomy or radiation treatment with contralateral breast cancer
- Taking chemo- or hormonal therapy at the time of the baseline breast MRI
- Estrogen and progesterone receptor negative breast cancer
- GFR less than GFR < 30 mL/min/1.73m2
- Postmenopausal women
- Pregnant and/or nursing women
- Less than 21 years of age
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Breast cancer
This prospective study will recruit patients with stage 0-3 breast cancer who have had or are scheduled for a breast MRI prior to treatment.
|
Baseline Breast-MRI within 1 year before starting tamoxifen (allows for surgery, chemotherapy and radiation before the start of tamoxifen). During Tamoxifen Treatment:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To compare the level of BPE on breast MRI
기간: 3 years
|
on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue
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3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To compare the amount of fibroglandular tissue on breast MRI
기간: 3 years
|
on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue
|
3 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Valencia King, MD, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
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 연구와 관련된 용어
기타 연구 ID 번호
- 10-217
- Mskcc 10-217 (기타 식별자: Memorial Sloan-Kettering Cancer Center)
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