ClinicalTrials.Veeva

Menu

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

Yale University logo

Yale University

Status and phase

Completed
Phase 2

Conditions

Liver Cancer

Treatments

Drug: Lipiodol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01877187
J12115
HIC1601017054 (Other Identifier)
NA_00074005 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

39 participants in 1 patient group

Lipiodol
Other group
Description:
Lipiodol, 10cc per TACE.
Treatment:
Drug: Lipiodol

Trial documents
2

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems