A PRospective evaluation of impact of additional Imaging modalities in Surgical Management and outcome in Treatment naive breast Cancer patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Percentage of proportion of change in surgical plan due to contrast based imaging findings.
研究概览
简要总结
This prospective interventional study is designed to evaluate the role of additional pre-operative imaging modalities Magnetic Resonance Imaging (MRI) and Contrast-Enhanced Mammography (CEM) in optimizing the surgical management of treatmen naive breast cancer patients. Eligible patients with newly diagnosed, biopsy confirmed invasive breast cancer who have not received any prior treatment will first undergo standard imaging workup including mammography and ultrasound. Subsequently, participants will receive MRI and/or CEM within two weeks prior to planned surgery. The surgical team will use all imaging data to determine the extent and type of surgery needed. The study aims to assess how MRI and CEM influence surgical decision making by measuring changes in surgical plans, additional lesion detection rates, and the concordance between imaging findings and final histopathology. Post-operative outcomes including margin status, reoperation rates, and complications will be documented. Follow-up assessments will be conducted up to three months after surgery to monitor patient recovery and surgical efficacy. The study seeks to provide evidence on whether incorporating MRI and CEM improves surgical outcomes and patient management in breast cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Patients consenting for participation in the study.
- •Non-metastatic at the time of presentation.
- •Mammogram, USG, CEM and MRI either performed in TMH, or done outside, with adequate quality DICOM images uploaded on PACS.
- •Patients undergoing CEM guided or MRI guided or relook USG guided biopsy if indicated at TMH/ACTREC; but may not undergo breast conservative surgery {These patients will be included in the study as rad- path correlation of these additional findings will be available}
- •Patients undergoing surgical and/ or medical management at TMH/ACTREC.
- •Biopsy specimen if eligible and complete surgical specimen provided to our institutional pathology department.
排除标准
- •Pregnant patients.
- •Metastatic disease at the time of presentation.
- •More than 18 years of age.
结局指标
主要结局
Percentage of proportion of change in surgical plan due to contrast based imaging findings.
时间窗: at 6 month
Events considered as change in surgical plan due to additional findings will be following categories:
时间窗: at 6 month
Category 1. Breast conservative surgery to mastectomy
时间窗: at 6 month
Category 2. Mastectomy to breast conservative surgery
时间窗: at 6 month
Category 3. For cases remaining as breast conservative surgery, extended resection leading to either expected change in cosmesis or requirement of oncoplasty due to contrast based imaging finding will be considered as change in management.
时间窗: at 6 month
Category 4. Decision to start NACT.
时间窗: at 6 month
次要结局
- 1. Comparison of disease extent on non-contrast-based imaging (Mammogram, USG), based on CEM and/or MRI (the modality which will determined the surgical outcome) & clinically determined extent of disease with histopathological extent of disease.
研究者
Dr Palak Thakkar
Tata Memorial Centre
