Freehand Ultrasound Elasticity Imaging in Liver Surgery

NCT00942383 | Terminated DMC

• 2 other identifiers: J0765NA_00011327
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential for visualizing radiofrequency-induced (RFA) and microwave-induced (MWA) hepatic thermal ablation lesions using a novel, high resolution, and freehand ultrasound elasticity imaging method in human subjects.

Conditions

Liver Tumors

Keywords

liver tumor; liver tumors; liver cancer; hepatocellular carcinoma; metastatic colorectal cancer; metastatic cancer to the liver; metastatic cancer; metastatic neuroendocrine cancer; liver; liver surgery; radiofrequency ablation; microwave ablation

Outcome Measures

Primary Outcomes (1)

• Comparison of transverse ablation diameter between intraoperative ultrasound elasticity imaging (USEI) and postoperative cross-sectional imaging (CT or MRI).

  2 years

Secondary Outcomes (4)

• Comparison of ablation volume between ultrasound elasticity imaging (USEI) and CT/MRI.

  2 years

• Correlation between "in vivo" versus phantom tumor size to validate the development of guidance systems combined with appropriate visualization and planning software for ablative therapy.

  2 years

• Feasibility of image acquisition using Siemens Anteras clinical free-hand system.

  2 years

• Feasibility of image processing and image segmentation using this clinical free-hand system.

  2 years

Study Arms (1)

IOUS-USEI

Receive intraoperative ultrasound (IOUS) using the Siemens Anteras to acquire ultrasound elasticity imaging (USEI) during standard of care surgical radiofrequency ablation and microwave ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are undergoing open, laparoscopic or percutaneous radiofrequency ablation (RFA) or microwave ablation (MWA) as treatment for liver tumors.

You may qualify if:

• Any patient eligible for open, laparoscopic, or percutaneous hepatic RFA or MWA as their surgical treatment due to either primary tumors of the liver as well as liver metastases.
• Participants must be able to have post-operative CT/MRI at Johns Hopkins as their standard care.

You may not qualify if:

• Patients under 18 years old.
• Pregnant women.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

SKCCC

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Study Officials

• Michael A Choti, M.D.

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 20, 2009
• Study Start: September 1, 2007
• Primary Completion: June 13, 2012
• Study Completion: June 13, 2012
• Last Updated: March 28, 2019

Record last verified: 2011-08

Locations

US (1)