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

Hepatic Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698643
• Other study ID #: RECHMPL18_0136
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: May 1, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age > or = 18 years

• primary or secondary liver tumor(s)

• TACE approved by multidisciplinary tumor meeting

Exclusion criteria:

• TACE not performed

Related Conditions & MeSH terms

• Hepatic Tumor
• Liver Neoplasms

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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