- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03698643
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).
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Montpellier, Frankrike, 34295
- Uhmontpellier
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion criteria:
- Age > or = 18 years
- primary or secondary liver tumor(s)
- TACE approved by multidisciplinary tumor meeting
Exclusion criteria:
- TACE not performed
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient effective radiation dose per TACE
Tidsramme: 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). |
1 day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Air kerma per TACE
Tidsramme: 1 day
|
Air kerma (in mGy) per TACE
|
1 day
|
|
Fluoroscopy time per TACE
Tidsramme: 1 day
|
Fluoroscopy time (in sec) per TACE
|
1 day
|
|
Number of CBCT acquisitions per TACE
Tidsramme: 1 day
|
Number of CBCT acquisitions per TACE
|
1 day
|
|
Number of CT acquisitions per TACE
Tidsramme: 1 day
|
Number of CT acquisitions per TACE
|
1 day
|
|
Treatment targeting
Tidsramme: 1 day
|
Assessed on control CBCT or CT and graded into 3 classes : fully targeted, partially targeted or untargeted.
|
1 day
|
|
Tumor response
Tidsramme: 1 day
|
Assessed on follow-up CT or MRI and graded into 3 classes : response, tumor stability or progression.
|
1 day
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: BORIS GUIU, PU-PH, University Hospital, Montpellier
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RECHMPL18_0136
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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