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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03698643

Enrollment

145

Registered

2018-10-09

Start date

2018-04-01

Completion date

2018-05-01

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Tumor

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- TACE not performed

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results