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临床试验/CTRI/2025/10/096116
CTRI/2025/10/096116尚未招募不适用

Influence of body habitus on hepatic enhancement and contrast media dose optimization in abdominopelvic CT: A Prospective Study

Jyoti Garg1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
256
试验地点
1
主要终点
To assess the correlation between body size parameters (TBW, LBW, BSA, FFM, AFR) and hepatic enhancement, and to evaluate image quality (quantitative and qualitative) in low- and normal-BMI groups at 80 and 100 kVp.

研究概览

简要总结

The study aims to evaluate the influence of body habitus on liver enhancement and contrast dose optimization in abdominal CT. It will be conducted in two phases. In Phase 1, patients with low and normal BMI will undergo CT scans at 80 and 100 kVp using a fixed contrast dose to assess the correlation between body size parameters such as total body weight, lean body weight, body surface area, fat-free mass, and abdominal fat ratio with hepatic enhancement and image quality. In Phase 2, the most predictive body size parameter identified in Phase 1 will be used to individualize and optimize the contrast dose. The optimized protocol will then be compared with the standard fixed-dose protocol. The main outcome measures will include liver enhancement in Hounsfield units, contrast to noise ratio, and qualitative image quality scores.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Those who are aged 18 years or above will be included.
  • Low and Normal BMI patients and Patient receiving only Iohexol contrast of concentration 300 mgI/ml.

排除标准

  • Trauma & Emergency cases Patients with conditions such as liver cirrhosis, severe fatty liver, as assessed through USG reports, which can change the density of the organs.
  • Pathologies such as hepatocellular carcinoma (HCC) requiring higher contrast volumes.
  • Patients with an allergy to iodinated contrast Patients with High creatinine level Patients with high BMI.

结局指标

主要结局

To assess the correlation between body size parameters (TBW, LBW, BSA, FFM, AFR) and hepatic enhancement, and to evaluate image quality (quantitative and qualitative) in low- and normal-BMI groups at 80 and 100 kVp.

时间窗: 1.5 years

次要结局

  • To develop an optimized contrast dosing protocol based on the most predictive body size parameter and compare liver enhancement and image quality before and after optimization.(1.5 years)

研究者

发起方
Jyoti Garg
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jyoti Garg

Manipal College of Health Professions (MCHP), MAHE

研究点 (1)

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