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临床试验/NCT04970498
NCT04970498Unknown不适用

Application of MRI Quantitative Parameters in Identifying Myelosuppression Risk of Neoadjuvant Chemoradiotherapy for Rectal Cancer

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Changes of ADC map of MRI

研究概览

简要总结

Rectal cancer patients who received neoadjuvant chemoradiotherapy in Peking University Third Hospital in 2021 are divided into acute myelosuppression group, chronic myelosuppression group and normal group. The differences of magnetic resonance parameters between the groups were compared. The risk identification model of acute and chronic myelosuppression after neoadjuvant chemoradiotherapy was established by clinical risk factors and quantitative parameters of magnetic resonance imaging, and the prediction efficiency of the model was evaluated.

详细描述

The patients with locally advanced rectal cancer diagnosed in Peking University Third Hospital and undergoing neoadjuvant chemoradiotherapy were collected. The basic information of patients (including age, sex, BMI, TNM stage of rectal cancer (T2, T3 stage)) was collected. The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy. MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed, and the corresponding parameters were obtained. The white blood cell values and quantitative parameters of magnetic resonance (including T1WI, DWI signal intensity (b = 1000) and proton density fat fraction (PDFF) of sacrilium and proximal femur were collected. Patients were divided into acute myelosuppression group and non-acute myelosuppression group according to blood routine results 14 days after radiotherapy, and chronic myelosuppression group and non-chronic myelosuppression group according to blood routine results 90 days after radiotherapy. The magnetic resonance parameters difference between 1-2 weeks after radiotherapy and before radiotherapy, and the magnetic resonance parameters difference between 90 days after radiotherapy and before radiotherapy were calculated. By comparing the differences of clinical risk factors and quantitative parameters of MRI between the two groups, the meaningful variables were screened out, and the risk identification model of acute and chronic myelosuppression was established.

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

入选标准

  • From February 2021 to August 2022, patients with locally advanced rectal cancer were treated with neoadjuvant chemoradiotherapy in the Third Hospital of Peking University.
  • There were blood routine before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy, and MRI examination including routine MRI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks and 90 days after radiotherapy.
  • Each patient used the same chemotherapy regimen.

排除标准

  • Patients with metabolic bone diseases such as hyperparathyroidism and Cushing's syndrome.
  • Patients with history of pelvic radiotherapy or systemic chemotherapy.
  • Patients with leukocytes below 4.0×10^9/L or long-term severe anemia before radiotherapy.
  • Patients with tumor bone metastases; patients with pelvic trauma, fracture, and infectious diseases.

结局指标

主要结局

Changes of ADC map of MRI

时间窗: 90 days after radiotherapy

The differences of ADC value(mm\^2/s) between the chronic myelosuppression group and no suppression group

Changes of DWI sequence of MRI

时间窗: 90 days after radiotherapy

The differences of DWI signal intensity(IU)between the chronic myelosuppression group and no suppression group

Changes of T1WI sequence of MRI

时间窗: 90 days after radiotherapy

The differences T1WI signal intensity(IU)between the chronic myelosuppression group and no suppression group

Changes of IDEAL-IQ sequence of MRI

时间窗: 90 days after radiotherapy

The differences of PDFF(%) between the chronic myelosuppression group and no suppression group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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