Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI. (TACE)

• ClinicalTrials.gov Identifier: NCT00539253
• Recruitment Status: Completed
• First Posted: October 4, 2007
• Results First Posted: September 26, 2017
• Last Update Posted: September 26, 2017
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bracco Diagnostics, Inc
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Hepatocellular Carcinoma
• Intervention: Drug: gadobenate dimeglumine (MultiHance)
• Enrollment: 45

Participant Flow

Recruitment Details	January, 2008 to May, 2012 People with hepatocellular carcinoma who were candidates for TACE who were referred to Johns Hopkins Hospital.
Pre-assignment Details	none observed

Arm/Group Title	Gadabenate Dimeglumine( Multihance)
Arm/Group Description	If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MRI imaging for both the baseline and 1 month f/u studies.
Period Title: Overall Study
Started	45
Completed	19
Not Completed	26

Baseline Characteristics

Arm/Group Title		Gadobenate Dimeglumine (Multi Hance)
Arm/Group Description		If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Overall Number of Baseline Participants		45
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	45 participants
		60.9; (43 to 73)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	Female	12 26.7%
	Male	33 73.3%
Region of Enrollment [1]; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	45 participants
		45 100.0%
		[1] Measure Description: Percentage of enhancement changes observed using Triple-phase MultiHance-enhanced MRI

Outcome Measures

1. Primary Outcome

Title	Nodule Size
Description	Maximal nodule size measured in centimeters
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed reflects the number of participants for whom data was available.

Arm/Group Title	Multihance
Arm/Group Description:	If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: centimeters
	6.4 (4.5)

2. Primary Outcome

Title	Nodule Enhancement
Description	Percent area of nodule with enhancement
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

Number of participants analyzed reflects the number of participants for whom data was available

Arm/Group Title	Multihance
Arm/Group Description:	If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Overall Number of Participants Analyzed	19
Mean (Standard Deviation); Unit of Measure: percent enhancement
	32.8 (30.7)

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Gadobenate Dimeglumine (Multi Hance)
Arm/Group Description	If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
All-Cause Mortality
	Gadobenate Dimeglumine (Multi Hance)
	Affected / at Risk (%)
Total	0/45 (0.00%)
Serious Adverse Events
	Gadobenate Dimeglumine (Multi Hance)
	Affected / at Risk (%)
Total	0/45 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Gadobenate Dimeglumine (Multi Hance)
	Affected / at Risk (%)
Total	0/45 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Ihab R. Kamel, M.D. PhD
• Organization: Johns Hopkins Hospital
• Phone: 410-955-4567
• EMail: ikamel@jhmi.edu

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00539253
• Other Study ID Numbers: J06108; NA_00003943 ( Other Identifier: Johns Hopkins I.R.B. )
• First Submitted: October 2, 2007
• First Posted: October 4, 2007
• Results First Submitted: October 12, 2016
• Results First Posted: September 26, 2017
• Last Update Posted: September 26, 2017