Status:
COMPLETED
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Lead Sponsor:
Yale University
Collaborating Sponsors:
Guerbet
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Childs class of A or B (up to 9).
- 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).
- Subject is voluntarily participating in the study and has signed the informed consent.
Exclusion
- Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used).
- Evidence of severe or uncontrolled systemic diseases.
- 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.
- Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication).
- Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable.
- Subject is breastfeeding.
- Subject is pregnant
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01877187
Start Date
April 1 2013
End Date
February 1 2020
Last Update
April 15 2020
Active Locations (2)
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1
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
2
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287