Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: Lipiodol
Intervention description: 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).
Intervention MeSH terms: Ethiodized Oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary liver cancer; Metastatic liver cancer

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/PET scans and blood tests (to include assessment of
      liver function and tumor markers).
    

Eligibility 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