BCT 2001 (Breast MRI Evaluation): Evaluation of clinical pathways and patient outcomes for breast magnetic resonance imaging (MRI) in preoperative assessment and staging of breast cancer: Establishing when MRI improves patient outcomes and when it does not. A multicentre prospective observational trial (Population B Prospective Study)

Breast Cancer Trials0 个研究点目标入组 406 人开始时间: 2020年3月3日最近更新: 2022年8月29日

适应症

试验速览

暂无简介。

•For inclusion in the study, participants must fulfil all the following criteria:
•1) Provide written, informed consent to participate in the study.
•2) Female >= 18 years with newly diagnosed early or locally advanced breast cancer for local staging and:
•a. With ultrasound/mammography, clinical examination results that are discrepant with respect to surgical and other treatment planning; AND/OR
•b. < 70 years with invasive lobular cancer; AND/OR
•c. < 50 years; AND/OR
•d. With reported extreme breast density on mammogram (as defined by the local site); AND/OR
•e. Breast diagnostic team suggests MRI may contribute to management.
•3) Must have had pre-MRI treatment plan determined by diagnostic/treatment team including:
•a. Type of planned breast and axillary surgery;
•b. Type of planned radiotherapy to breast/node/chest wall;
•c. Type of planned systemic therapy (including chemotherapy, HER2 directed therapy, endocrine therapy, neoadjuvant therapy).
•4) Be willing and able to comply with requirements of study.
•5) Completed baseline PROMs after signing consent and willing to complete specified PROMs in English throughout out the study.

•Any one of the following is regarded as a criterion for exclusion from the study:
•1) Distant metastatic disease beyond the breast and locoregional ipsilateral lymph nodes.
•2) Locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement.
•3) Previous cancer on the same side.
•4) Classical lobular carcinoma in situ (LCIS) (pleomorphic LCIS is acceptable).
•5) Other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent curative intent surgery to the breast primary and lymph nodes.
•6) Undergone study specific MRI before registration. Study specific MRI can only occur after registration.
•7) Unable to undergo MRI:
•a. MRI is not suitable for participants with any of the following: pacemaker, implanted non-MRI compatible devices, cochlear implants, neurostimulators, insulin infusion pumps, estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2.
•b. Compatibility checks are required for: aneurysm clips, those with a history of metallic ocular foreign bodies, vascular coils, stents and filters, eye implants and heart valve replacements.

发起方