Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01877187
First received: March 27, 2013
Last updated: March 24, 2014
Last verified: March 2014

March 27, 2013
March 24, 2014
April 2013
May 2015   (final data collection date for primary outcome measure)
Measuring Lipiodol deposition in tumor [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging.
Same as current
Complete list of historical versions of study NCT01877187 on ClinicalTrials.gov Archive Site
Determining the time period of survival [ Time Frame: Baseline to 4 years ] [ Designated as safety issue: No ]
We will determine the amount of time of survival for subjects after treatment.
Same as current
Not Provided
Not Provided
 
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Liver Cancer
Drug: Lipiodol
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).
Other Name: Ethiodol
Lipiodol
Lipiodol, 10cc per TACE.
Intervention: Drug: Lipiodol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Diane Reyes, RN 410-614-4212 dreyes1@jhmi.edu
United States
 
NCT01877187
J12115, NA_00074005
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Guerbet
Not Provided
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP