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 |
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.
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
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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