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

NCT02057874 | Terminated Results DMC

• 1 other identifier: VICC GI 1343
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Correlation of Changes in Imaging Biomarkers (Ktrans, ADC, MTR, and APTasym) as Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively, With Changes in Tumor Volume (mRECIST).

  The following will be longitudinally measured using 3 Tesla (3T) magnetic resonance imaging (MRI) prior to transarterial chemoembolization (TACE) and 2-4, 4-8, and 12 weeks following TACE: 1) the volume transfer coefficient (Ktrans), measured by dynamic contrast-enhanced (DCE) MRI; 2) the apparent diffusion coefficient (ADC), measured by diffusion-weighted (DW) MRI; 3) the magnetization transfer ratio (MTR), measured by magnetization transfer (MT) MRI; and 4) the amide proton transfer asymmetry (APTasym), measured by chemical exchange saturation transfer (CEST) MRI. We will use a general linear model (GLM) approach to measure the association between changes in each of the above imaging metrics (relative to pretreatment baseline) and changes in tumor volume (according to standard-of-care modified RECIST) at 3 or 6 month follow-up, accounting for the effect of potential confounders, e.g., age and size of the tumor at baseline.

  Baseline to up to 12 weeks post-TACE

Secondary Outcomes (4)

• Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Time-to-progression (TTP).

  Baseline to up to 6 months post-TACE

• Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Changes in the Ratio of Viable-to-necrotic Tumor Volume

  Baseline to up to 12 weeks post-TACE

• Correlation of Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Pathological Response Within Explanted Tissue Following Orthotopic Liver Transplant (OLT)

  Subset of patients undergoing OLT: within 12 hours following surgery

• Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Overall Survival (OS)

  Baseline to up to 6 months post-TACE

Study Arms (1)

Diagnostic (3T MRI)

EXPERIMENTAL

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.

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

Interventions

3 Tesla Magnetic Resonance Imaging 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.

Also known as: 3 Tesla MRI, 3T MRI (Philips Achieva), multi-parametric imaging

Diagnostic (3T MRI)

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

Also known as: intravenous (IV) injection of Magnevist® (gadopentetate dimeglumine); IV contrast infusion; IV gadolinium (Gd)

Diagnostic (3T MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Gadolinium DTPA; Gadolinium

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Results Point of Contact

• Title: Professor of Surgery and Cancer Biology
• Organization: Vanderbilt University Medical Center

lee.gorden@vanderbilt.edu

615-936-2956

Study Officials

• David L Gorden, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery (Hepatobiliary and Liver Transplantation)

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: February 1, 2014
• Primary Completion: November 19, 2015
• Study Completion: December 4, 2015
• Last Updated: July 11, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-07

Locations

US (1)