Hepatic Xenetix-CT Perfusion

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01639703
• Date of registration: 06/07/2012
• Prospective Registration: No
• Primary sponsor: Guerbet
• Public title: Hepatic Xenetix-CT Perfusion
• Scientific title: Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma
• Date of first enrolment: April 2012
• Target sample size: 96
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01639703
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Austria, Germany, Korea, Republic of, Switzerland

Contacts

• Name: Hatem Alkadhi
• Affiliation: Zurich University Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Intervention(s)

Drug: Xenetix-CT perfusion imaging

Primary Outcome(s)

Permeability Surface (PS) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Blood Flow (BF) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Blood Volume (BV) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Secondary Outcome(s)

Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Blood Volume According to Immunohistochemistry Parameter (CD31) [Time Frame: Within a week from CT perfusion to surgery]

Permeability Surface According to Immunohistochemistry Parameter (CD31) [Time Frame: Within a week from CT perfusion to surgery]

Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase) [Time Frame: Within a week from CT perfusion to surgery]

Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Blood Flow According to Immunohistochemistry Parameter (CD31) [Time Frame: Within a week from CT perfusion to surgery]

Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase) [Time Frame: Within a week from CT perfusion to surgery]

Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase) [Time Frame: Within a week from CT perfusion to surgery]

Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation [Time Frame: Within a week from CT perfusion to surgery]

Secondary ID(s)

ISO-44-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01639703