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

NCT01877187 | Completed Phase 2 Results DMC

• 3 other identifiers: J12115NA_00074005HIC1601017054
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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).

Conditions

Liver Cancer

Keywords

Primary liver cancer; Metastatic liver cancer

Outcome Measures

Primary Outcomes (2)

• 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

  30 days, 90 days, and 180 days

• 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.

  30 days, 90 days, 180 days

Secondary Outcomes (9)

• Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

  30 days, 90 days, and 180 days

• Baseline Enhancing Tumor and Response by mRECIST Criteria

  30 days, 90 days, 180 days

• Tumor Response by World Health Organization (WHO) Criteria

  6 months

• Baseline Enhancing Tumor and Response by WHO Criteria

  30 days, 90 days, 180 days

• Tumor Response by European Association for the Study of the Liver (EASL) Criteria

  6 months

Study Arms (1)

Lipiodol

OTHER

Lipiodol, 10cc per TACE.

Drug: Lipiodol

Interventions

Lipiodol DRUG

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).

Also known as: Ethiodol

Lipiodol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Guerbet: collaborator

Study Sites (2)

Smilow Cancer Center

New Haven, Connecticut, 06510, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Todd Schlachter, MD
• Organization: Yale University

todd.schlachter@yale.edu

(203) 785-5885

Study Officials

• Todd Schlachter, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: June 13, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 15, 2020
• Results First Posted: April 15, 2020

Record last verified: 2020-04

Locations

US (2)