Impact of New Interventional Imaging Modality Use on Patient Radiation Exposure in Transarterial Chemoembolization

Completed

• Conditions: Hepatic Tumor

• Registration Number: NCT03698643
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Transarterial chemoembolization (TACE) is the most performed endovascular interventional radiology (IR) procedure. TACE procedures are performed in an IR suite, most of which are equipped with floor-based flat-panel robotic C-arm allowing two-dimensional imaging. Cone-beam computed tomography (CBCT) has been developed to allow three-dimensional navigation but has several limitations such as reduced signal to noise ratio and small field-of-view, and seems to have negative impact on patient radiation exposure. Another option to perform 3D imaging is called angio-CT which combines a CT-scan and a floor-based flat-panel robotic C-arm in a single IR suite. Even if some publications have shown benefit of angio-CT in TACE procedures in Japan, no study about angio-CT in liver IR procedures has been conducted in the occidental world so far. The purpose of our study was to assess the impact of angio-CT use on patient radiation exposure and treatment quality in TACE procedures compared to CBCT.

This before-after study consisted of a review of consecutive TACE procedures performed between January 2016 and September 2017 in our institution with two different imaging modalities, defining two study groups (C-arm with CBCT versus angio-CT).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-05-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-10-05
• Last Update Submitted: 2018-10-05
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient effective radiation dose per TACE	1 day	Patient effective radiation dose (mSv) per TACE : Dose-area product (in mGy/cm\^2) and dose-length product (in mGy/cm) will be combined and converted to report effective dose (in mSv).

Secondary Outcome Measures

Name	Time	Method
Number of CBCT acquisitions per TACE	1 day	Number of CBCT acquisitions per TACE
Number of CT acquisitions per TACE	1 day	Number of CT acquisitions per TACE
Tumor response	1 day	Assessed on follow-up CT or MRI and graded into 3 classes : response, tumor stability or progression.
Treatment targeting	1 day	Assessed on control CBCT or CT and graded into 3 classes : fully targeted, partially targeted or untargeted.
Air kerma per TACE	1 day	Air kerma (in mGy) per TACE
Fluoroscopy time per TACE	1 day	Fluoroscopy time (in sec) per TACE

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France