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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: Lipiodol
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lipiodol
Lipiodol, 10cc per TACE.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877187

Contacts
Contact: Diane Reyes, RN 410-614-4212 dreyes1@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Jeff Geschwind, MD         
Sub-Investigator: Ihab Kamel, MD/ PhD         
Sub-Investigator: Timothy Pawlik, MD/ PhD         
Sub-Investigator: Michael Torbenson, MD         
Sub-Investigator: Richard Wahl, MD         
Sub-Investigator: Diane Reyes, RN         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Guerbet
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01877187     History of Changes
Other Study ID Numbers: J12115, NA_00074005
Study First Received: March 27, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Primary liver cancer
Metastatic liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Ethiodized Oil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 30, 2014