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

Stopped early · Not applicable

Conditions studied: 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)

In brief

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.

Key facts

Study ID

NCT02057874

Run by

Vanderbilt-Ingram Cancer Center

People needed

2

Starts

2014-02-01

Expected to finish

2015-12-04

Last updated by the study team

2018-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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