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OpenTrials
Completed

NCT Number: NCT03698643

Impact of New Interventional Imaging Modality Use 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • TACE not performed

Treatment and study plan

Primary outcomes

  1. Patient effective radiation dose per TACE

    Time frame: 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 outcomes

  1. Air kerma per TACE

    Time frame: 1 day

    Air kerma (in mGy) per TACE

  2. Fluoroscopy time per TACE

    Time frame: 1 day

    Fluoroscopy time (in sec) per TACE

  3. Number of CBCT acquisitions per TACE

    Time frame: 1 day

    Number of CBCT acquisitions per TACE

  4. Number of CT acquisitions per TACE

    Time frame: 1 day

    Number of CT acquisitions per TACE

  5. Treatment targeting

    Time frame: 1 day

    Assessed on control CBCT or CT and graded into 3 classes : fully targeted, partially targeted or untargeted.

  6. Tumor response

    Time frame: 1 day

    Assessed on follow-up CT or MRI and graded into 3 classes : response, tumor stability or progression.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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