Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT

NCT ID: NCT05790590

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-06-30

Brief Summary

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In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.

Detailed Description

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Conditions

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Metastasis to Liver Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard dose CT

Standard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner.

Group Type ACTIVE_COMPARATOR

Standard dose CT

Intervention Type DIAGNOSTIC_TEST

CT with standard radiation dose and contrast media dose

Double low dose CT

Double low dose protocol CT using low radiation dose (120 kVp \& 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.

Group Type EXPERIMENTAL

Double low dose CT

Intervention Type DIAGNOSTIC_TEST

Simultaneous reduction of both radiation dose and contrast media dose

Interventions

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Double low dose CT

Simultaneous reduction of both radiation dose and contrast media dose

Intervention Type DIAGNOSTIC_TEST

Standard dose CT

CT with standard radiation dose and contrast media dose

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* colorectal cancer (CRC) patients
* on surveillance or monitoring for liver metastasis (of CRC)

Exclusion Criteria

* any relative or absolute contra-indication of CECT
* diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyuna Jung

Role: CONTACT

82-2-2072-4177

Jeong Hee Yoon, MD

Role: CONTACT

82-2-2072-2293

Facility Contacts

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Hyuna Jung, RN

Role: primary

82-2-2072-4177

Other Identifiers

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SNUH-2022-3274

Identifier Type: -

Identifier Source: org_study_id

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