Deep Learning Radiogenomics For Individualized Therapy in Unresectable Gallbladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Develop and validate a deep learning radiomics (DLR) model for identification of HER2 status in unresectable gallbladder cancer (GBC) on computed tomography (CT)
研究概览
简要总结
The goal of this observational study is to learn about deep learning radiogenomics for individualized therapy in unresectable gallbladder cancer. The main questions it aims to answer are:
(i) whether a deep learning radiomics (DLR) model can be used for identification of HER2status and prediction of response to anti-HER2 directed therapy in unresectable GBC.
(ii) validation of the deep learning radiomics (DLR) model for identification of HER2 status and prediction of response to anti-HER2 directed therapy in unresectable GBC.
Participants will be asked to
- Undergo biopsy of the gallbladder mass after a baseline CT scan
- Based on the results of the biopsy, patients will be given chemotherapy either targeted (if Her2 positive) or non-targeted
- Response to treatment will be assessed with a CT scan at 12 weeks of chemotherapy
详细描述
This study aimed at investigating the treatment option for patients with unresectable GB cancer. Presently the treatment of unresectable GB cancer mainly palliative with chemotherapy regime limited to generic form of chemotherapy offer to patients with other GI cancer. There is evolving data regarding the role of genetic mutation in cancers. Recent studies have also shown multiple somatic and germline mutation in GB cancer. Some of these mutations are amiable to targeted therapy. The era of precision medicine assured new hopes for patient with unresectable cancer. There is some preliminary data that shows benefit of precision medicine in GB cancer as well. The estimation of targeted therapy relies on obtaining biopsy therapy on cancer which can often be challenging, associated with complication and less acceptable by the patients. Studies in some other cancer shows that genetic mutation can be predicted based on imaging characteristics, however no such study has been done in GB cancer. The fundamental hypothesis is that prediction of HER2 status and response to anti-HER2 directed therapy using deep learning radiomic models in unresectable GBC will allow researchers to fully harness the potential of targeted therapy in clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable mass-forming GBC
- •Patients willing to give informed consent
排除标准
- •Patients with prior chemotherapy for GBC
- •Patients with deranged RFTs
- •Patients with contrast allergy
结局指标
主要结局
Develop and validate a deep learning radiomics (DLR) model for identification of HER2 status in unresectable gallbladder cancer (GBC) on computed tomography (CT)
时间窗: 8 months
The DLR model identifying HER2 status in unresectable GBC will be developed using contrast enhanced CT scans of 150 patients (retrospective data). The accuracy of DLR will be validated a in a prospective contrast enhanced CT data of 75 patients.
Predict response to anti-HER2 directed therapy using DLR
时间窗: 12 weeks
DLR will be used to predict response to targeted therapy in prospective cohort of HER2+ GBC patients on follow up CT at 12 weeks using RECIST 1.1
次要结局
未报告次要终点
研究者
Pankaj Gupta
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh
