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出境医 / 临床实验 / Reducing Iodine Dose Based on Lean Body Weight

Reducing Iodine Dose Based on Lean Body Weight

Study Description
Brief Summary:
This study aims to assess whether the acceptable image quality is achievable using low contrast media dose calculated based on lean body weight and low keV imaging for the detection of hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Body Weight Other: low dose CT contrast media - lean body weight Other: Standard dose CT contrast media Not Applicable

Detailed Description:
Currently, the contrast media dose is calculated based on total body weight. However, the human body is composed of adipose tissue and non-adipose tissue, and adipose tissue contributes little to the volume of distribution for contrast media. Therefore, iodine dose calculated based on lean body weight would be more personalized than merely considering total body weight. In addition, lowering the contrast media dose would be achievable by using virtual monoenergetic imaging at low keV. Therefore, we aimed to assess whether the acceptable image quality is achievable using low contrast media dose calculated based on lean body weight and low keV imaging for the detection of hepatocellular carcinoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Detection of Hepatocellular Carcinomas Using Virtual Monoenergetic Imaging With Reduced Iodine Dose Based on Lean Body Weight
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Low dose - lean body weight
Low CT contrast media dose calculated based on lean body weight
 Other: low dose CT contrast media - lean body weight
CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.
Active Comparator: Standard dose
Standard CT contrast media dose calculated based on total body weight
 Other: Standard dose CT contrast media
CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.
Outcome Measures
Primary Outcome Measures :
  1. lesion conspicuity [ Time Frame: 6 months after complete enrollment ]
    qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)


Secondary Outcome Measures :
  1. Image noise [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)

  2. Image contrast [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)

  3. Overall image quality [ Time Frame: 6 months after complete enrollment ]
    qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)

  4. Lesion detection [ Time Frame: 12 months after complete enrollment ]
    assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)

  5. Hounsfield unit [ Time Frame: 3 months after complete enrollment ]
    measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles

  6. Contrast media dose [ Time Frame: 3 months after complete enrollment ]
    administered contrast media dose in each group

  7. Radiation dose [ Time Frame: 3 months after complete enrollment ]
    measured radiation dose in each group


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk group for developing HCC
  • Scheduled contrast-enhanced CT for HCC diagnosis or surveillance

Exclusion Criteria:

  • not a high risk group for developing HCC
  • body mass index is equal to or larger than 30 kg/m^2
  • suspected HCC > 5cm in diameter
  • received locoregional treatment or surgery for HCC within 3 months
  • congestive hepatopathy
  • no venous access on forearm
  • anticipated beam hardening artifact due to prosthesis
  • relative/absolute contraindication of contrast-enhanced CT
Contacts and Locations

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Siemens Corporation, Corporate Technology
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE June 27, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2021) 		lesion conspicuity [ Time Frame: 6 months after complete enrollment ]
qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		lesion conspicuity [ Time Frame: 12 months after complete enrollment ]
qualitative scoring for focal lesion depiction on five-point scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
  • Image noise [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)
  • Image contrast [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)
  • Overall image quality [ Time Frame: 6 months after complete enrollment ]
    qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)
  • Lesion detection [ Time Frame: 12 months after complete enrollment ]
    assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)
  • Hounsfield unit [ Time Frame: 3 months after complete enrollment ]
    measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles
  • Contrast media dose [ Time Frame: 3 months after complete enrollment ]
    administered contrast media dose in each group
  • Radiation dose [ Time Frame: 3 months after complete enrollment ]
    measured radiation dose in each group
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Image noise [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for focal image contrast on four-point scale: 1, poor; 4, good
  • Image contrast [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for focal image contrast on four-point scale: 1, poor; 4, good
  • Overall image quality: four-point scale [ Time Frame: 6 months after complete enrollment ]
    qualitative scoring for focal image contrast on four-point scale: 1, poor; 5, good
  • Lesion detection [ Time Frame: 12 months after complete enrollment ]
    assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)
  • Hounsfield unit [ Time Frame: 3 months after complete enrollment ]
    measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles
  • Contrast media dose [ Time Frame: 3 months after complete enrollment ]
    administered contrast media dose in each group
  • Radiation dose [ Time Frame: 3 months after complete enrollment ]
    measured radiation dose in each group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Iodine Dose Based on Lean Body Weight
Official Title  ICMJE Detection of Hepatocellular Carcinomas Using Virtual Monoenergetic Imaging With Reduced Iodine Dose Based on Lean Body Weight
Brief Summary This study aims to assess whether the acceptable image quality is achievable using low contrast media dose calculated based on lean body weight and low keV imaging for the detection of hepatocellular carcinoma.
Detailed Description Currently, the contrast media dose is calculated based on total body weight. However, the human body is composed of adipose tissue and non-adipose tissue, and adipose tissue contributes little to the volume of distribution for contrast media. Therefore, iodine dose calculated based on lean body weight would be more personalized than merely considering total body weight. In addition, lowering the contrast media dose would be achievable by using virtual monoenergetic imaging at low keV. Therefore, we aimed to assess whether the acceptable image quality is achievable using low contrast media dose calculated based on lean body weight and low keV imaging for the detection of hepatocellular carcinoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Carcinoma, Hepatocellular
  • Body Weight
Intervention  ICMJE
  • Other: low dose CT contrast media - lean body weight
    CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.
  • Other: Standard dose CT contrast media
    CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.
Study Arms  ICMJE
  • Experimental: Low dose - lean body weight
    Low CT contrast media dose calculated based on lean body weight
    Intervention: Other: low dose CT contrast media - lean body weight
  • Active Comparator: Standard dose
    Standard CT contrast media dose calculated based on total body weight
    Intervention: Other: Standard dose CT contrast media
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • High risk group for developing HCC
  • Scheduled contrast-enhanced CT for HCC diagnosis or surveillance

Exclusion Criteria:

  • not a high risk group for developing HCC
  • body mass index is equal to or larger than 30 kg/m^2
  • suspected HCC > 5cm in diameter
  • received locoregional treatment or surgery for HCC within 3 months
  • congestive hepatopathy
  • no venous access on forearm
  • anticipated beam hardening artifact due to prosthesis
  • relative/absolute contraindication of contrast-enhanced CT
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027556
Other Study ID Numbers  ICMJE SNUH-2019-0344
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeong Min Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Siemens Corporation, Corporate Technology
Investigators  ICMJE
Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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