NCT06719414招募中不适用
A Multi-center Study on Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
Sixth Affiliated Hospital, Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response
研究概览
简要总结
The goal of this observational study is to learn about the amide proton transfer-weighted imaging for rectal cancer response assessment after neoadjuvant therapy. The main question it aims to answer is:
• Does amide proton transfer-weighted imaging predict the cancer response before surgery? Participants will underwent amide proton transfer-weighted imaging as part of their regular MRI examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced rectal cancer(cT3-4, or cN+), resectable, histologically confirmed rectal adenocarcinoma
- •Received neoadjuvant therapy before surgery
- •Complete radical resection of rectal cancer and postoperative pathological examination
- •Informed consent and signed the informed consent form
排除标准
- •Poor image quality, such as severe artifacts
- •Complicated with intestinal obstruction, intestinal perforation and other cases requiring surgical treatment
- •The interval between preoperative MRI and surgery was more than 2 weeks
- •Prior treatment for rectal cancer
- •History of other malignant tumors
- •Patients who cannot undergo MRI examination due to contraindications or relative contraindications
- •Patients were lost to follow-up or voluntarily withdrew from the study due to adverse reactions or other reasons
结局指标
主要结局
the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response
时间窗: From date of baseline MRI to date of preoperative MRI，within 12 months
次要结局
- the specificity of models in prediction tumor response(From date of baseline MRI to date of preoperative MRI，within 12 months)
- the sensitivity of models in prediction tumor response(From date of baseline MRI to date of preoperative MRI，within 12 months)
- the positive predictive value of models in prediction tumor response(From date of baseline MRI to date of preoperative MRI，within 12 months)
- the negative predictive value of models in prediction tumor response(From date of baseline MRI to date of preoperative MRI，within 12 months)
- the accuracy of models in prediction tumor response(From date of baseline MRI to date of preoperative MRI，within 12 months)
- disease-free survival and overall survival(From date of enrollement until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Peiyi Xie
associate chief physician
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Amide proton transfer imaging of the lesions in the orofacial regioTumorous lesions in the orofacial regionsJPRN-UMIN000018793Kyushu University, Faculty of dental science.60
终止
不适用
Pilot Study Using Amide Proton Transfer Magnetic Resonance Imaging Distinguishing GliomaGliosarcomaGliomaNCT03843814Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins13
招募中
不适用
Amide proton transfer imaging for malignant brain tumor and spinal tumorMalignant brain tumor, spinal tumorJPRN-UMIN000030794ational Cancer Center Hospital80
进行中（未招募）
1 期
Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With GlioblastomaGlioblastoma Multiforme (GBM)NCT04019002Susan Chang17
终止
不适用
Quantitative Imaging and Proton Spectroscopy in Multiple SclerosisMultiple SclerosisNCT01226654NYU Langone Health69