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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01877187
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: Lipiodol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
Actual Study Start Date : April 2013
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 30 days, 90 days, and 180 days ]

    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. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:

    Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >= 30% decrease in the sum of the longest diameter of target lesions

    Overall Response (OR) = CR + PR


  2. Baseline Enhancing Tumor and Response by RECIST Criteria [ Time Frame: 30 days, 90 days, 180 days ]
    Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects.


Secondary Outcome Measures :
  1. Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST) [ Time Frame: 30 days, 90 days, and 180 days ]

    Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with mRECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per modified Response Evaluation Criteria in Solid Tumors (mRECIST):

    Complete Response (CR): Disappearance of all intratumoral arterial enhancement in target lesions Partial Response (PR): At least 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions Overall Response (OR) = CR + PR


  2. Baseline Enhancing Tumor and Response by mRECIST Criteria [ Time Frame: 30 days, 90 days, 180 days ]
    Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by mRECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by mRECIST criteria. Nonresponders are all other subjects.

  3. Tumor Response by World Health Organization (WHO) Criteria [ 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 WHO response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per WHO criteria:

    Complete Response (CR): disappearance of all lesions for >= 4 weeks. Partial Response (PR): At least 50% decrease in sum of the products of diameters of target lesions.

    Overall Response: CR + PR.


  4. Baseline Enhancing Tumor and Response by WHO Criteria [ Time Frame: 30 days, 90 days, 180 days ]
    Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by WHO criteria. Responders are subjects that demonstrated Complete Response or Partial Response by WHO criteria. Nonresponders are all other subjects.

  5. Tumor Response by European Association for the Study of the Liver (EASL) Criteria [ 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 EASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per EASL response:

    Complete Response (CR): complete disappearance of enhancing tissue in target lesions Partial Response (PR): At least 50% decrease in area of enhancing tissue in target lesions.

    Overall Response: CR+PR


  6. Baseline Enhancing Tumor and Response by EASL Criteria [ Time Frame: 30 days, 90 days, 180 days ]
    Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by EASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by EASL criteria. Nonresponders are all other subjects.

  7. Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria [ 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 qEASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per qEASL criteria:

    Complete Response (CR): Total disappearance of enhancing tumor volume in target lesions Partial Response (PR): At least 65% decrease in enhanced tumor volume after treatment.

    Overall Response: CR + PR


  8. Baseline Enhancing Tumor and Response by qEASL Criteria [ Time Frame: 30 days, 90 days, 180 days ]
    Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by qEASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by qEASL criteria. Nonresponders are all other subjects.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877187


Locations
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United States, Connecticut
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Yale University
Guerbet
Investigators
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Principal Investigator: Todd Schlachter, MD Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Informed Consent Form  [PDF] August 16, 2017

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01877187    
Other Study ID Numbers: J12115
NA_00074005 ( Other Identifier: Johns Hopkins Institutional Review Board )
HIC1601017054 ( Other Identifier: Yale University )
First Posted: June 13, 2013    Key Record Dates
Results First Posted: April 15, 2020
Last Update Posted: April 15, 2020
Last Verified: April 2020
Keywords provided by Yale University:
Primary liver cancer
Metastatic liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Ethiodized Oil
Antineoplastic Agents