3-Tesla MRI Response to TACE in HCC (Liver Cancer)

• Status: Terminated
• Trial end date: 2015-12-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)

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