3-Tesla MRI Response to TACE in HCC (Liver Cancer)
Adult Primary Hepatocellular Carcinoma - Advanced Adult Primary Liver Cancer - Localized Resectable Adult Primary Liver Cancer - Localized Unresectable Adult Primary Liver Cancer - Stage A Adult Primary Liver Cancer (BCLC) - Stage B Adult Primary Liver Cancer (BCLC)
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Study Type
Study Phase
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: 3 Tesla Magnetic Resonance Imaging Type: Device
Name: Magnevist® (Intravenous (IV) administration of MRI contrast agent) Type: Drug
Overall Status
This pilot clinical trial examines how well different imaging biomarkers acquired using 3-Telsa magnetic resonance imaging (MRI) methods perform in determining treatment response to transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma. Compared to conventional imaging, multi-parametric 3-Tesla MRI offers the ability to quantitatively measure tissue structural, functional, cellular, and molecular properties, providing a more robust, clinically relevant method for assessing cancer response to therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Subjects must have signed an institutional review board (IRB)-approved informed consent document

- Subjects must have verified unresectable hepatocellular carcinoma (HCC), diagnosed on the basis of clinical and imaging criteria

- Subjects must be classified as TNM stage I, II, or III; alternatively, subjects may be classified as Barcelona Clinic Liver Cancer (BCLC) stage A or B

- Subjects must be scheduled to undergo transarterial chemoembolization (TACE)

- Subjects must have at least 1 lesion being targeted by TACE that is > 2 cm in the longest cross-sectional (axial plane) diameter

- Subjects must satisfy one of the following conditions pertaining to their eligibility to undergo orthotopic liver transplantation (OLT):

- HCC that is within Milan Criteria, i.e., TACE is indicated as a "bridge" to OLT (Group I); or

- HCC that is outside Milan Criteria, i.e., TACE is indicated as a means of "down-staging" into transplant eligibility (Group II)

Exclusion Criteria:

- Subjects who have received prior treatment for HCC (prior surgical procedures not related to HCC are allowed)

- Subjects who have undergone prior radioembolization

- Subjects with a central venous line

- Subjects who have any type of biomedical implant, device and/or ferromagnetic material that can be displaced, perturbed, or otherwise malfunction due to mechanical, electronic, or magnetic means; these items may include:

- Metallic fragments or shrapnel (such as from war wounds)

- Cerebral aneurysm clips, biopsy marker clips

- Vascular access ports (as are used with intravenous chemotherapy)

- Cochlear implants, pacemakers, neurostimulators, biostimulators, and electronic infusion pumps **Implanted materials other than those verified as being rated "magnetic resonance [MR] Safe" or "MR Conditional 6" will not be allowed on study

- Creatinine >= 1.5 times upper limit of normal

- Estimated glomerular filtration rate (eGFR) < 30 mL/min

- Subjects who are pregnant or nursing

- Subjects who have had past allergic or other adverse reactions to intravenous injection of Magnevist® (gadopentetate dimeglumine) or other gadolinium-containing contrast agents

- Subjects who exhibit noticeable anxiety, claustrophobia, or vertigo when moved into the scanner

- Subjects incapable of giving informed written consent, for the following reasons:

- Inability to adhere to the experimental protocols for any reason

- Inability to communicate with the research team

- Mental disability, altered mental status, confusion, or psychiatric disorders

- Prisoners or others susceptible to coercion
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: VICC Clinical Trials Information Program - 800-811-8480
Start Date
February 2014
Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page