An Assessment of the Impact of CONTrast ENhanceD Mammography (CESM) on Patient Management and Comparison With MRI (CONTEND Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Assessment of impact the addition of CESM has on patient management - does this lead to an earlier diagnosis / treatment plan
研究概览
简要总结
The aim of this study is to determine if the addition of Contrast Enhanced Spectral Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient management - discharge, follow-up, surgery or treatment - being made sooner than it would if the patient had followed the standard course of investigations and review.
详细描述
Women with suspicious breast lesions following mammography and ultrasound will be eligible for the study. Those who consent to participate will be randomised either to receive Contrast Enhanced Spectral Mammography (CESM) in addition to standard care or to receive standard care alone.
Women randomised to receive CESM will undergo the procedure either during the same visit or if necessary on another date within a week. Any additional suspicious lesions detected by CESM will be biopsied along with the original lesion either under ultrasound or x-ray guidance. Biopsy of suspicious lesions is standard care and not part of the research protocol. Those randomised to receive standard care will undergo ultrasound or x-ray guided biopsy of any suspicious lesion identified by ultrasound or mammography.
Results of all biopsies will be discussed at the next multidisciplinary (MDT) meeting where a treatment decision (conservation surgery, mastectomy or neoadjuvent therapy) will be made for those with confirmed disease. MRI will be performed on appropriate women in line with standard practice. Additional disease detected by MRI will be biopsied, either under ultrasound or MRI guidance, if this will influence patient management. The results from these cases will be discussed at the next MDT meeting.
For those women in either arm of the study with benign biopsy results standard care will be followed.
A proforma will be used to record patient pathway, biopsy results and MDT patient management decisions for each case.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to give written informed consent for participation in the study.
- •Have a lesion of suspicion 3, 4 or 5 following mammography and ultrasound.
排除标准
- •Known or suspected pregnancyBreast implant
- •Previous breast cancer
- •Known renal impairment
- •History of anaphylactoid or anaphylactic reaction to any contrast media
- •Contrast media within 24 hours prior to CESM
- •Commencement of neo-adjuvant chemotherapy, hormone treatment, radiotherapy or surgery for this episode
结局指标
主要结局
Assessment of impact the addition of CESM has on patient management - does this lead to an earlier diagnosis / treatment plan
时间窗: Retospective analysis at end of data collection period ( approximately I year)
The pathway of each participant through the diagnostic process will be reviewed at the end of the data collection period to assess whether the addition of CESM resulted in a definitive decision regarding treatment being made earlier than in the usual diagnostic route.
次要结局
未报告次要终点
研究者
Professor Fiona J Gilbert
Professor of Radiology, Department Head
University of Cambridge