Hepatic TumorNCT03698643
Impact of New Interventional Imaging Modality Use on Patient Radiation Exposure in Transarterial Chemoembolization
An observational study of Hepatic Tumor, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Tumor
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: TACE sessions performed on adult patients with primary or secondary liver tumor(s) after multidisciplinary tumor meeting approval
Who may be able to join
- Age > or = 18 years
- primary or secondary liver tumor(s)
- TACE approved by multidisciplinary tumor meeting
Who cannot join
- TACE not performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Hepatic Tumor
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (6)
Air kerma per TACE
Air kerma (in mGy) per TACE
Measured: 1 day
Fluoroscopy time per TACE
Fluoroscopy time (in sec) per TACE
Measured: 1 day
Number of CBCT acquisitions per TACE
Number of CBCT acquisitions per TACE
Measured: 1 day
Number of CT acquisitions per TACE
Number of CT acquisitions per TACE
Measured: 1 day
Treatment targeting
Assessed on control CBCT or CT and graded into 3 classes : fully targeted, partially targeted or untargeted.
Measured: 1 day
Tumor response
Assessed on follow-up CT or MRI and graded into 3 classes : response, tumor stability or progression.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Apr 2018
- Primary completion30 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS GUIU, PU-PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698643
- Sponsor's protocol ID
- RECHMPL18_0136
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of New Interventional Imaging Modality Use (Angio-CT) on Patient Radiation Exposure in Transarterial Chemoembolization
- ClinicalTrials.gov ID
- NCT03698643
- Acronym / sponsor ID
- RECHMPL18_0136
- Conditions
- Hepatic Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TACE sessions performed on adult patients with primary or secondary liver tumor(s) after multidisciplinary tumor meeting approval
Key inclusion criteria (3 listed)
- Age > or = 18 years
- primary or secondary liver tumor(s)
- TACE approved by multidisciplinary tumor meeting
Key exclusion criteria (1 listed)
- TACE not performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Air kerma per TACE
Time frame: 1 day
Fluoroscopy time per TACE
Time frame: 1 day
Number of CBCT acquisitions per TACE
Time frame: 1 day
Number of CT acquisitions per TACE
Time frame: 1 day
Treatment targeting
Time frame: 1 day
Tumor response
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BORIS GUIU, PU-PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Tumor, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient effective radiation dose per TACE (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.