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

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ClinicalTrials.gov Identifier: NCT02057874
Recruitment Status : Terminated (Funding unavailable)
First Posted : February 7, 2014
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Lee Gorden, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
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)
Interventions Device: 3 Tesla Magnetic Resonance Imaging
Drug: Magnevist® (Intravenous (IV) administration of MRI contrast agent)
Enrollment 2
Recruitment Details Participants were recruited to this trial at Vanderbilt University Medical Center from 02/06/2014 to 11/19/2015. The study closed prematurely due to a loss of funding.
Pre-assignment Details  
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/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.

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.

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.

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
participant did not return for scan             1
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/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.

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.

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.

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
60  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title 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).
Hide Description 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.
Time Frame Baseline to up to 12 weeks post-TACE
Hide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding data were not collected
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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).
Hide Description Proportional hazard model will be employed to assess the ability of the longitudinal change (relative to pretreatment baseline) in each of the 3T MR imaging metrics (Ktrans, ADC, MTR, and APTasym) to predict patient survival outcomes, time-to-progression (TTP) and progression-free survival (PFS) as well as overall survival (OS). The calibration of prediction will be validated by computing the difference between predicted survival and Kaplan-Meier survival estimates at a fixed time, which estimates the over-optimism of the difference using bootstrapping.
Time Frame Baseline to up to 6 months post-TACE
Hide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding data were not collected
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/Group Description:
Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4...
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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
Hide Description Longitudinal changes in 3T MRI-derived measures and the change in the ratio of viable vs. necrotic tumor will be assessed by using a GLM approach in which the underlying temporal correlation can be modeled via an autoregressive order one (AR(1)) structure, validated by computing Akaike Information Criterion (AIC) against the other common structures, e.g., unstructured and constant correlation.
Time Frame Baseline to up to 12 weeks post-TACE
Hide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding data were not collected
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/Group Description:
Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4...
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title 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)
Hide Description Histopathological features on explanted livers following OLT, including percentage necrosis and cellular density as determined by hematoxylin and eosin staining, as well as the extent of fibrosis as determined by collagen staining, will be assessed for correspondence with findings on ex vivo 3T MRI.
Time Frame Subset of patients undergoing OLT: within 12 hours following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding data were not collected
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/Group Description:
Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4...
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title 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)
Hide Description Proportional hazard model will be employed to assess the ability of the longitudinal change (relative to pretreatment baseline) in each of the 3T MR imaging metrics (Ktrans, ADC, MTR, and APTasym) to predict patient survival outcomes, time-to-progression (TTP) and progression-free survival (PFS) as well as overall survival (OS). The calibration of prediction will be validated by computing the difference between predicted survival and Kaplan-Meier survival estimates at a fixed time, which estimates the over-optimism of the difference using bootstrapping.
Time Frame Baseline to up to 6 months post-TACE
Hide Outcome Measure Data
Hide Analysis Population Description
Due to loss of funding data were not collected
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/Group Description:
Patients undergo 3T MRI at baseline (=< 2 weeks before TACE) and at 2-4 weeks, 4...
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (3T MRI)
Hide Arm/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.

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.

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.

All-Cause Mortality
Diagnostic (3T MRI)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Serious Adverse Events
Diagnostic (3T MRI)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diagnostic (3T MRI)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor of Surgery and Cancer Biology
Organization: Vanderbilt University Medical Center
Phone: 615-936-2956
EMail: lee.gorden@vanderbilt.edu
Layout table for additonal information
Responsible Party: David Lee Gorden, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02057874    
Other Study ID Numbers: VICC GI 1343
First Submitted: February 5, 2014
First Posted: February 7, 2014
Results First Submitted: April 12, 2018
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018