Can Quantitative MRI After cTACE Help Predict Survival ?

NCT ID: NCT02173119

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-03-07

Brief Summary

Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected into an artery (blood vessel) directly supplying blood to a HCC tumor.

Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to quantify the amount of lipiodol delivered to the HCC tumors.

In this study, the investigators want to see if patient survival is related to the amount of lipiodol delivered to HCC tumors.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC patients having MRI post-TACE

HCC patients who have undergone conventional lipiodol based chemoembolization.

MRI post-TACE

Intervention Type: OTHER

Perform lipiodol delivery measurements with MRI post-TACE.

Interventions

MRI post-TACE

Perform lipiodol delivery measurements with MRI post-TACE.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Prospective studies will be performed in 20 patients with Hepatocellular Carcinoma (HCC) independently scheduled to undergo TACE; tumors in each of these candidates will already have been deemed un-resectable.
• Reasons may include

• concurrent co-morbidities including cardiac or respiratory compromise
• recurrent or multi-lobar disease
• cirrhosis or portal hypertension
• vascular invasion
• high tumor burden
• contraindications to general anesthesia.
• Diagnosis of HCC will have been established by a) biopsy or b) non-invasively, based upon > 2cm diameter tumor with characteristic imaging findings in the setting of cirrhosis.
• Male or female aged 18 to 89 years, all ethnicities

• Pregnant women.
• Individuals with pacemakers or other non-MRI compatible metallic implants.
• Hemodialysis patients or patients with severely impaired renal function.
• Individuals with severe claustrophobia or unwilling to get a MRI.

Exclusion Criteria

• Infiltrative or diffuse HCC.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Sarah B. White

MD, Assistant Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah B. White, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Countries

United States

References

Gordon AC, Lewandowski RJ, Li W, Zhong X, Kannengiesser SAR, Miller FH, Salem R, Rilling WS, Larson AC, White SB. Chemical Shift MRI Monitoring of Chemoembolization Delivery for Hepatocellular Carcinoma: Multicenter Feasibility of Initial Clinical Translation. Radiol Imaging Cancer. 2023 May;5(3):e220019. doi: 10.1148/rycan.220019.

Reference Type: DERIVED

PMID: 37233207 (View on PubMed)

Other Identifiers

PRO22746

Identifier Type: -

Identifier Source: org_study_id