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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01877187
First received: March 27, 2013
Last updated: April 21, 2017
Last verified: April 2017
March 27, 2013
April 21, 2017
April 2013
October 2017   (Final data collection date for primary outcome measure)
Tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 6 months ]
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.
Measuring Lipiodol deposition in tumor [ Time Frame: Baseline to 6 months ]
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.
Complete list of historical versions of study NCT01877187 on ClinicalTrials.gov Archive Site
6-month survival rate of patients with HCC and liver metastases treated with conventional TACE [ Time Frame: 6 months ]
Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional.
Determining the time period of survival [ Time Frame: Baseline to 4 years ]
We will determine the amount of time of survival for subjects after treatment.
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/PET scans and blood tests (to include assessment of liver function and tumor markers).
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
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.
 
Active, not recruiting
39
October 2017
October 2017   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01877187
J12115
NA_00074005 ( Other Identifier: Johns Hopkins Institutional Review Board )
HIC1601017054 ( Other Identifier: Yale University )
Yes
Not Provided
Not Provided
Yale University
Yale University
Guerbet
Principal Investigator: Jean-Francois (Jeff) Geschwind, MD Yale University
Yale University
April 2017

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