Low-dose Radiation Abdominal Computed Tomography

• Sponsor: Wei Li (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06142539
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

Purpose: To evaluate the image quality of deep learning-based image reconstruction (DLIR) algorithm in unenhanced abdominal low-dose CT (LDCT).

Methods: CT images of a phantom were reconstructed with Hybrid iterative reconstruction and deep learning image reconstruction (DLIR). The noise power spectrum (NPS) and task transfer function (TTF) were measured. Two patient groups were included in this study: consecutive patients who underwent unenhanced abdominal standard-dose CT reconstructed with hybrid iterative reconstruction (SDCT group) and consecutive patients who underwent unenhanced abdominal LDCT reconstructed of HIR and DLIR (LDCT group). The CT values, standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle and abdominal subcutaneous fat were evaluated. Radiologists assessed the subjective image quality and lesion diagnostic confidence using a 5-point Likert scale. Quantitative and qualitative parameters were compared between SDCT and LDCT groups.

Condition or Disease	Intervention/Treatment	Phase
CT Examination of the Abdomen	Radiation: CT Radiation Doses

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Deep Learning Image Reconstruction in Low-dose Radiation Abdominal Computed Tomography: a Comparison of Image Quality and Radiation Dose
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Mar 28, 2024
• Anticipated Study Completion Date: Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
SDCT group
LDCT group	Radiation: CT Radiation Doses; Obtaining Low CT Radiation Doses by Adjusting Dose Levels

Outcome Measures

Primary Outcome Measures

1. Results of phantom research [up to six months]

   Compare the changes in spatial resolution (TTF curve) and noise (NPS curve) between different algorithms

2. Results of human clinical study [up to six months]

   General information of clinical trial personnel Compare the general information of two groups of subjects, such as age, weight（kg）, height（m）, gender, and BMI (kg/m2). Quantitative image analysis The standard deviation (SD), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) of the hepatic parenchyma and paraspinal muscle were evaluated. Qualitative image analysis Two radiologists qualitatively assessed the overall image noise and overall image quality depiction.

Secondary Outcome Measures

1. Patient demographics [up to six months]

   Participant demographics: Age (year)/Gender/Body weight (kg) / Body mass index (kg/m2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Abdominal CT examination

Exclusion Criteria:

pregnancy and lactation for women unstable breath holding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	uCT960+	Shandong	Jinan Shandong	China	250000

Sponsors and Collaborators

• Wei Li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei Li, clinical professor, Qianfoshan Hospital
• ClinicalTrials.gov Identifier: NCT06142539
• Other Study ID Numbers: WLi
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Nov 21, 2023