Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

Hepatocellular Carcinoma Clinical Trial

Official title:

Blood Volume Assessment of Hepatocellular and Metastatic Carcinomas in the Liver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288910
• Other study ID #: 14030305
• Status: Completed
• Start date: November 2014
• Est. completion date: July 2020

Study information

• Verified date: October 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project investigates the feasibility of assessing the relative blood volume of carcinomas in patients with Hepatocellular Carcinoma (HCC) and liver metastases from pancreatic or colorectal cancer compared to normal liver from DynaCT acquisitions on an interventional platform.

Description:

This project will enroll patients with non-diffuse liver disease who are candidates for chemo or radioembolization to treat or manage the disease during an image guided intervention. Subjects will undergo a CT perfusion study of the liver prior to the radioembolizaiton mapping procedure or prior to the chemoembolization treatment. During the radioembolization mapping or chemoembolization procedure, 2 DynaCT acquisitions on the interventional C-arm will be acquired (the second during an injection of an iodinated contrast material) and will be processed using Siemens' PBV software to generate blood volume maps. The diagnostic accuracy of the two approaches to assess the vascularity of the tumors will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HCC or metastatic liver disease

• Candidate for radioembolization or chemoembolization

Exclusion Criteria:

• Pregnant

• Iodine allergy

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Metastatic Carcinoma to the Liver

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of PBV maps	The accuracy of the DynaCT BV protocol as an indicator of healthy vs. liver tumor compared to the body CT perfusion study will evaluated using a receiver operating characteristic curve.	1 year
Secondary	Relationship between blood volume values and patient treatment response	The relationship between the BV values obtained by both methods and treatment response (as measured by RECIST values) will be evaluated by a logistic regression model	1,4,7,13,19 months
Secondary	PBV blood volume value accuracy	A Spearman's correlation coefficient will be used to test the rank-based correlation of the BV values in tumor from the DynaCT BV acquisition to the body CT perfusion values. Furthermore, a paired t-test will be used to test for differences in BV using the two approaches.	1 year