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Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma


Inclusion Criteria:



- Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation)
within a timeframe of 30 days between first imaging procedure used for the study and
surgery.

Exclusion Criteria:

- Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA
(Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one
year before inclusion.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Perfusion parameters and histology grade

Outcome Description:

Correlation between perfusion parameters and histology grade using CT perfusion exam and pathology findings

Outcome Time Frame:

within a week before surgery

Safety Issue:

No

Principal Investigator

Hatem Alkadhi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zurich University Hospital

Authority:

Switzerland: Swissmedic

Study ID:

ISO-44-013

NCT ID:

NCT01639703

Start Date:

April 2012

Completion Date:

June 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • CT perfusion
  • Hepatocellular Carcinoma
  • Xenetix
  • Contrast agent
  • Carcinoma
  • Carcinoma, Hepatocellular

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