Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Conditions
Liver Cancer
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Primary liver cancer, Metastatic liver cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Lipiodol
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/ CT scans and blood tests (to include assessment of liver function and tumor markers). After the 6th month, patients will be followed every 2-3 months for a period of up to 4 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. 18 years of age or older.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

3. Childs class of A or B (up to 9).

4. Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or subject has HCC and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC).

5. Subject is voluntarily participating in the study and has signed the informed consent.

Exclusion Criteria:

1. Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used).

2. Evidence of severe or uncontrolled systemic diseases.

3. Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.

4. Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication).

5. Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable.

6. Subject is breastfeeding.

7. Subject is pregnant
Location
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Status: Recruiting
Start Date
April 2013
Sponsors
Sidney Kimmel Comprehensive Cancer Center
Source
Sidney Kimmel Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page