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

NCT ID: NCT02057874

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-04

Brief 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.

Conditions

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (3T MRI)

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.

Group Type: EXPERIMENTAL

3 Tesla Magnetic Resonance Imaging

Intervention Type: DEVICE

3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.

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

Intervention Type: DRUG

For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes.

Interventions

3 Tesla Magnetic Resonance Imaging

3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.

Intervention Type: DEVICE

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

For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes.

Intervention Type: DRUG

Other Intervention Names

3 Tesla MRI, 3T MRI (Philips Achieva), multi-parametric imaging; intravenous (IV) injection of Magnevist® (gadopentetate dimeglumine); IV contrast infusion; IV gadolinium (Gd)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

David Lee Gorden

Professor of Surgery (Hepatobiliary and Liver Transplantation)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David L Gorden, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Related Links

http://www.vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

VICC GI 1343

Identifier Type: -

Identifier Source: org_study_id