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

Impact of New Interventional Imaging Modality Use (Angio-CT) on Patient Radiation Exposure in Transarterial Chemoembolization

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).

Study Overview

• Status: Completed
• Conditions: Hepatic Tumor

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

TACE sessions performed on adult patients with primary or secondary liver tumor(s) after multidisciplinary tumor meeting approval

Description

Inclusion criteria:

• Age > or = 18 years
• primary or secondary liver tumor(s)
• TACE approved by multidisciplinary tumor meeting

Exclusion criteria:

- TACE not performed

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient effective radiation dose per TACE	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).	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: BORIS GUIU, PU-PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: RECHMPL18_0136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No