Multi-Parametric 3 Tesla Magnetic Resonance Imaging (MRI) of Response to Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC)
Overview
- Phase
- Not Applicable
- Intervention
- 3 Tesla Magnetic Resonance Imaging
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
David Lee Gorden
Professor of Surgery (Hepatobiliary and Liver Transplantation)
Vanderbilt-Ingram Cancer Center
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
Arms & Interventions
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.
Intervention: 3 Tesla Magnetic Resonance Imaging
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.
Intervention: Magnevist® (Intravenous (IV) administration of MRI contrast agent)
Outcomes
Primary Outcomes
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).
Time Frame: Baseline to up to 12 weeks post-TACE
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.
Secondary Outcomes
- 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 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 Changes in the Ratio of Viable-to-necrotic Tumor Volume(Baseline to up to 12 weeks post-TACE)
- 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)