Back to resultsLipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lipiodol
Sponsored by
About this trial
This is an interventional other trial for Liver Cancer focused on measuring Primary liver cancer, Metastatic liver cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Smilow Cancer Center
- The Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lipiodol
Arm Description
Lipiodol, 10cc per TACE.
Outcomes
Primary Outcome Measures
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
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
Baseline Enhancing Tumor and Response by RECIST Criteria
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
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
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
Baseline Enhancing Tumor and Response by mRECIST Criteria
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.
Tumor Response by World Health Organization (WHO) Criteria
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.
Baseline Enhancing Tumor and Response by WHO Criteria
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.
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
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
Baseline Enhancing Tumor and Response by EASL Criteria
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.
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
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
Baseline Enhancing Tumor and Response by qEASL Criteria
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.
6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE
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.
Full Information
NCT ID
NCT01877187
First Posted
March 27, 2013
Last Updated
April 2, 2020
Sponsor
Yale University
Collaborators
Guerbet
1. Study Identification
Unique Protocol Identification Number
NCT01877187
Brief Title
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Official Title
Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Guerbet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Primary liver cancer, Metastatic liver cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipiodol
Arm Type
Other
Arm Description
Lipiodol, 10cc per TACE.
Intervention Type
Drug
Intervention Name(s)
Lipiodol
Other Intervention Name(s)
Ethiodol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Description
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
Time Frame
30 days, 90 days, and 180 days
Title
Baseline Enhancing Tumor and Response by RECIST Criteria
Description
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.
Time Frame
30 days, 90 days, 180 days
Secondary Outcome Measure Information:
Title
Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Description
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
Time Frame
30 days, 90 days, and 180 days
Title
Baseline Enhancing Tumor and Response by mRECIST Criteria
Description
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.
Time Frame
30 days, 90 days, 180 days
Title
Tumor Response by World Health Organization (WHO) Criteria
Description
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.
Time Frame
6 months
Title
Baseline Enhancing Tumor and Response by WHO Criteria
Description
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.
Time Frame
30 days, 90 days, 180 days
Title
Tumor Response by European Association for the Study of the Liver (EASL) Criteria
Description
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
Time Frame
6 months
Title
Baseline Enhancing Tumor and Response by EASL Criteria
Description
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.
Time Frame
30 days, 90 days, 180 days
Title
Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria
Description
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
Time Frame
6 months
Title
Baseline Enhancing Tumor and Response by qEASL Criteria
Description
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.
Time Frame
30 days, 90 days, 180 days
Title
6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Schlachter, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smilow Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
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