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Активно (без набиране) Не е приложимо NCT05797545

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

Не е приложима фаза (напр. обсервационно)
Заболявания: Breast Neoplasms Breast Cancer

Спонсор: Samsung Medical Center

Налично на: БГ
Обобщение
The goal of this randomized clinical trial is to compare diagnostic results of secondary breast cancer surveillance using breast ultrasound abbreviated MRI and full protocol MRI.
Описание
Women who have been treated for breast cancer are at risk of ipsilateral local/regional recurrence or new primary cancers in the contralateral breast, which are associated with increased rates of distant metastases and breast cancer mortality. The goal of post-treatment imaging surveillance is to detect early second breast cancer, which permits interventions to improve survival and maintain quality of life. Currently, most guidelines consistently recommend annual mammography for women with a personal history of breast cancer (PHBC). However, in women with dense breasts, mammographic sensitivity decreased from a level of 85.7%-88.8% in patients with almost entirely fatty tissue to 62.2%-68.1%. Even more, sensitivity of mammography was lower in women with a PHBC within the initial 5 years after primary breast cancer (PBC) treatment. In addition, dense breasts lead to an increased percentage of interval cancer. Thus, the need for a better surveillance modality has emerged. In this context, breast US may be considered as a supplemental screening modality because it is widely available, does not need contrast agents, and is of relatively lower cost . A few studies indicate that adding screening US to mammography reduced interval cancer rates for women with dense breasts and enable detection of early-stage cancers at an average of 4.2 cancers per 1000 US examinations. As an another candidate, breast MRI shows high sensitivity and offers the highest cancer detection rate but its routine usage in women with a PHBC is still on debate. Another possible imaging modality is breast magnetic resonance imaging (MRI). Current National Comprehensive Cancer Network (NCCN) guidelines suggest annual screening with mammography and MRI is recommended for ① women with Breast Cancer Susceptibility Gene (BRCA1 or BRCA2) mutations, ② first-degree family members of carriers of BRCA mutations, ③ women with a lifetime risk of breast cancer greater than 20% based on family history, and ④ women have radiotherapy for thorax at the age of 10-30 years and ⑤ women diagnosed with lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH) by previous biopsy. And, this is based on the results of existing single-center or multi-center prospective studies. Women who underwent breast-conserving surgery for breast cancer before the age of 50 were added to the 2018 new MRI screening group of the American College of Radiology (ACR), and their secondary breast cancer risk is 20% or more. Most women with a history of breast cancer have an intermediate risk (\>15% but \<20%) of developing breast cancer. Therefore, when most patients are not in the high-risk group, performing conventional MRI (full-protocol MRI, FP-MRI) for all postoperative examinations is not appropriate in terms of cost and time. Abbreviated MRI (AB-MRI), introduced relatively recently, is a method designed to increase accessibility by reducing time and cost by selectively
Кой може да участва
Inclusion Criteria: * Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive breast cancer \[stage 0-3\]) * Women with dense breasts with pattern C (heterogeneously dense) or D (extremely dense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit Inc.) in the most recent mammography * Women who have not had a breast imaging test within 6 months * Women who agreed to undergo regular annual mammography, breast ultrasound, and breast MRI Exclusion Criteria: * Patients with symptoms related to current breast cancer or breast cancer recurrence (palpable mass, bloody or transparent nipple secretion, palpable mass in the axillary region, abnormal skin changes in the breast or nipple) * If you have been diagnosed with regional recurrence (axillary lymph nodes, supraclavicular and subclavian lymph nodes, internal mammary lymph nodes, etc.) or distant metastases * In case of bilateral total mastectomy * If women are receiving chemotherapy for cancer in other organs * Women during pregnancy or lactation * Glomerular filtration rate \< 30 mL/min/1.73m2, or patients with renal insufficiency on dialysis * If women have severe claustrophobia * If women have a metal prosthesis that is not suitable for MR (e.g. breast tissue expander, etc.) * If there is a history of severe contrast agent side effects (e.g., anaphylactoid reaction, dyspnea, etc.)
Интервенции
Breast MRI for Breast Cancer Detection
DIAGNOSTIC_TEST
Места на провеждане 3
Южна Корея (3)
Inje University Busan Paik Hospital
Busan , BusanJin-Gu
Samsung Medical center
Seoul , Gangnam-gu
Soon Chun Hyang University Hospital Seoul
Seoul , Yongsan-Gu
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
20 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
23.04.2023
Крайна дата
28.05.2028
Регистрационен номер
NCT05797545
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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