Clinical trial NCT01877187: Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Official title: Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Keywords: Primary liver cancer
Metastatic liver cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2013-06-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 30 days, 90 days, and 180 days
measure: Baseline Enhancing Tumor and Response by RECIST Criteria
timeFrame: 30 days, 90 days, 180 days
Secondary outcomes:
measure: Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: 30 days, 90 days, and 180 days
measure: Baseline Enhancing Tumor and Response by mRECIST Criteria
timeFrame: 30 days, 90 days, 180 days
measure: Tumor Response by World Health Organization (WHO) Criteria
timeFrame: 6 months
measure: Baseline Enhancing Tumor and Response by WHO Criteria
timeFrame: 30 days, 90 days, 180 days
measure: Tumor Response by European Association for the Study of the Liver (EASL) Criteria
timeFrame: 6 months
measure: Baseline Enhancing Tumor and Response by EASL Criteria
timeFrame: 30 days, 90 days, 180 days
measure: Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
timeFrame: 6 months
measure: Baseline Enhancing Tumor and Response by qEASL Criteria
timeFrame: 30 days, 90 days, 180 days
measure: 6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Cancer Center
state: Connecticut
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Yale University
name: Todd Schlachter, MD
role: PRINCIPAL_INVESTIGATOR
References: