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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Localized Resectable Adult Primary Liver Cancer; Advanced Adult Primary Liver Cancer; Stage A Adult Primary Liver Cancer (BCLC); Stage B Adult Primary Liver Cancer (BCLC); Localized Unresectable Adult Primary Liver Cancer; Adult Primary Hepatocellular Carcinoma

Treatments: Drug: Magnevist® (Intravenous (IV) administration of MRI contrast agent); Device: 3 Tesla Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02057874

VICC GI 1343

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Diagnostic (3T MRI)

Experimental group

Description:

Patients undergo 3T MRI at baseline (=\< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.

Treatment:

Device: 3 Tesla Magnetic Resonance Imaging

Drug: Magnevist® (Intravenous (IV) administration of MRI contrast agent)