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



Status:Terminated
Conditions:Liver Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/13/2018
Start Date:February 2014
End Date:December 4, 2015

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Multi-Parametric 3 Tesla Magnetic Resonance Imaging (MRI) of Response to Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC)

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.


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
We found this trial at
1
site
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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mi
from
Nashville, TN
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