Can Quantitative MRI After cTACE Help Predict Survival ?

NCT02173119 | Completed

• 1 other identifier: PRO22746
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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)

Keywords

Hepatocellular; Carcinoma; HCC; lipiodol

Outcome Measures

Primary Outcomes (1)

• Imaging response

  Imaging response will be assessed according to 3D European Association for the Study of the Liver (EASL) criteria. EASL criteria propose using contrast enhanced (CE) images to measure viable volumes. We will transfer all images to a computer workstation. We will measure 'viable' enhancing tumor volumes at each interval and percent change in viable tumor volume (change from baseline). We will correlate lipiodol delivery measurements to primary outcomes post-therapy.

  Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

Secondary Outcomes (4)

• Clinical response

  Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

• Adverse Events

  Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

• Time-to-Tumor Progression

  Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

• Survival

  Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.

Study Arms (1)

HCC patients having MRI post-TACE

HCC patients who have undergone conventional lipiodol based chemoembolization.

Other: MRI post-TACE

Interventions

MRI post-TACE OTHER

Perform lipiodol delivery measurements with MRI post-TACE.

HCC patients having MRI post-TACE

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma (HCC or cancer of the liver) and will soon undergo one or more transcatheter arterial chemoembolization (TACE) procedure(s).

You may qualify if:

• 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

You may not qualify if:

• Infiltrative or diffuse HCC.
• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Guerbet: collaborator
• Northwestern University: collaborator

Study Sites (1)

Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 37233207 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Sarah B. White, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor of Radiology

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 24, 2014
• Study Start: August 1, 2014
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)