Hepatic Xenetix-CT Perfusion

Guerbet

Status and phase: Completed; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Xenetix-CT perfusion imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639703

ISO-44-013

Details and patient eligibility

About

The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

CT perfusion

Experimental group

Description:

arm with CT perfusion

Treatment:

Drug: Xenetix-CT perfusion imaging