Detection Rate of Liver Metastases With Contrast Enhanced Intraoperative Ultrasound Compared to Regular Imaging

NCT01522209 | Completed DMC

• 1 other identifier: Asklepios
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The study compares the established imaging techniques (CT, MRT, Contrast Ultrasound) with the new method of intraoperative contrast enhanced ultrasound to compare all methods for their rate of detection of colorectal liver metastasis.

Conditions

Colon Cancer Liver Metastasis; Contrast Enhances Intraoperative Ultrasound; Imaging for Liver Cancer; Imaging for Liver Metastasis

Keywords

CRLM; Primovist MRI; CEIOUS

Outcome Measures

Primary Outcomes (1)

• Detection of Liver Metastasis during Operation

  Intraoperative Rate of Detection of Liver Metastasis compared to preoperative Imaging Analysis

  During Operation

Secondary Outcomes (3)

• Comparison of Detection Rate for Liver Metastases of all imaging modalities

  1 Week after Operation

• Comparison of Sensitivity of all imaging modalities

  one Year

• Comparison of Specicivity of all imaging modalities

  one year

Interventions

Liver Surgery PROCEDURE

R0 Resection of Liver Metastases after Planning with preoperative imaging data and comparison with intraoperative contrast enhanced ultrasound

Contrast Enhanced Ultrasound DEVICE

The contrast enhanced Ultrasound imaging is performed before and during the operation using Sonovue contrast agent (2.5ml iv preop, 4.5ml iv intraop)

CT Scan (standard) RADIATION

A staging CT of the liver/abdomen with the minimal possible dosage for aquiring sufficent triphasic data in a 64-line helical scan

Primovist MRI (3 Tesla) RADIATION

an MRI scan of the liver with Primovist contrast agent including late phase as addition to the preop staging according to the protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent Age \> 18 years All Patients presenting with Colorectal Liver Metastasis indicated for Liver Surgery in the study period

You may not qualify if:

• No Informed Consent Possible Pregnancy Patients with hereditary diseases of the metabolic system Liver Cirrhosis CHILD B and C Renal Insufficiency defined as Kreatinin \>2,5 mg/dl PAtients enrolled in other studies

Sponsors & Collaborators

• Asklepios Kliniken Hamburg GmbH: lead

Study Sites (1)

Asklepios Hospital Barmbek

Hamburg, Hamburg, 22291, Germany

Location

Related Publications (24)

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  PMID: 34159555 DERIVED

Study Officials

• Gregor A Stavrou, Dr.med

  Dpt. of General and Visceral Surgery, Asklepios Hospital Barmbek, Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 31, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

DE (1)