Studio BoCCE: Ruolo Della Biopsia Sotto Guida CEM (Mammografia Con Mezzo di Contrasto) Nella Caratterizzazione Delle Calcificazioni Dubbie o Sospette (BIRADS R3, R4, R5) Non Associate a Masse.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Distance in mm between the biopsy site and the area of greatest malignancy/grade in the operating piece.
研究概览
简要总结
Calcification clusters are 30-40% of recalls in mammographic screening, but have a low positive predictive value (~15%) for ductal cancer in situ (DCIS) or invasive cancer. These calcifications often need histological assessment with stereotaxic guided biopsy (Mammotome). With extended calcifications, choosing the best area to biopsy may be challenging.
The main objective of this 1:1 randomized controlled clinical trial is to compare the accuracy of the CESM guide (study arm with biopsy under CESM guidance) with the traditional Mammotome (control arm with biopsy under stereotactic guidance) in conducting the biopsy in the area of greatest malignancy/grade of the lesion, using as gold-standard the histological exam of the operating piece. Women recalled with indication to perform stereotactic biopsy for clusters of suspicious calcifications on mammography (BIRADS R3 or R4 or R5) not mass-associated will be included. Anticipated sample size is 100 women per arm.
详细描述
Rationale Suspicious calcifications requiring further assessment are about 30-40% of recalls in mammographic screening. Nevertheless these findings have low positive predictive value (~15%) for ductal cancer in situ (DCIS) or invasive cancer. However, these calcifications are more frequently sent to biopsy than other doubt or suspect findings, due the difficulty in resolving the suspect with ultrasounds or with other imaging techniques.
For their histological check a biopsy with stereotaxic guidance (Mammotome) should be performed; when calcifications appear in several distinct clusters or over extended area, it is difficult to choose the best area to biopsy.
CESM is a technique that fuses mammographic images able to capture the morphology of calcifications (not visible at MRI) and the enanchement due to metabolic cellular and tissue vascular changes (not visible at usual X-ray imaging). Contrast-enhanced mammography (CESM) allows the description of both morphology and distribution of calcifications and contrast enhancement (CE). In the identification of pathological calcifications, CESM showed 91% sensitivity, 84% specificity, 77% VPP and 93% VPN, providing additional information for cancer diagnosis and dimensional definition of the pathological area.
This technique has the potential to allow a better sampling when biopsing calcifications than standard stereotactic biopsy.
Main objective: to compare the accuracy of CESM guide vs. stereotactic Mammotome guide in conducting biopsy in the area of major malignancy/grade of lesion.
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
- Single (Outcomes Assessor)
盲法说明
Pathology results will be blindly reviewed by external pathologists.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with clinical mammography and screening recalls with mammographic confirmation of clusters of suspicious calcifications (BIRADS R3 or R4 or R5) not mass-associated will be included, with indication to perform stereotactic biopsy, evaluated at the Breast Care Facility of AUSL-IRCCS in Reggio Emilia.
排除标准
- •Women with contraindication to the administration of iodized contrast medium will be excluded.
研究组 & 干预措施
Contrast enhanced mammography guided biopsy
Patients will be subjected to CESM; the two orthogonal mammographic projections, after intravenous administration of iodized contrast-enhancement (Omnipaque), will be performed.
Surgical and medical treatments will be defined accordingly to the imaging and histological findings obtained with the experimental procedure.
干预措施: Contrast enhanced mammography guided biopsy (diagnostic procedure) (Other)
mammography guided biopsy
Patients will be subjected to stereotactic biopsy Mammotome as normal clinical practice.
Surgical and medical treatments will be defined accordingly to the imaging and histological findings obtained with the standard procedure.
干预措施: Mammography guided biopsy (diagnostic procedure) (Other)
结局指标
主要结局
Distance in mm between the biopsy site and the area of greatest malignancy/grade in the operating piece.
时间窗: Cross-sectional: the reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. In any case, it cannot be collected more than 6 months after biopsy.
In patients sent to surgery, the main outcome will be determined on the operating piece by a single pathologist operating in blind, which will assess the type of lesion (B1-B5), invasiveness, grade, the extent of the lesion in mm, the percentage of invasive component, the distance in mm between the location of the biopsy and the area of greatest malignancy (DCIS G3 or invasive component). In patients not sent to surgery, the outcome will be determined by following the patients for a follow-up of at least 24 months, verifying if they have undergone surgery on that specific lesion during the follow-up (in particular if they have developed B5 lesions in situ or invasive in that location).
次要结局
- Proportion of patients needing contrast imaging(Cross-sectional: the reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. In any case, it cannot be collected more than 6 months after biopsy.)
- Biopsy sensitivity(The reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. Women not needing surgery (negative at biopsy) will be followed up for 24 months in orther to assess the presence of cancers.)
- Accuracy for lesion size(Cross-sectional: the reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. In any case, it cannot be collected more than 6 months after biopsy.)
- Association between enhancement and grade(Cross-sectional: the reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. In any case, it cannot be collected more than 6 months after biopsy.)
- Diagnosis upgrading(Cross-sectional: the reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. In any case, it cannot be collected more than 6 months after biopsy.)
- Waiting time between biopsy and surgery(The outcome measure is the time from biopsy to first surgical intervention, usually this time is in the range of 3 to 6 weeks.)
- Accuracy for multifocality(Cross-sectional: the reference standard will be collected during surgery, usually 3 to 6 weeks after biopsy. In any case, it cannot be collected more than 6 months after biopsy.)