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

Tracking Information

• First Submitted Date: October 2, 2007
• First Posted Date: October 4, 2007
• Results First Submitted Date: October 12, 2016
• Results First Posted Date: September 26, 2017
• Last Update Posted Date: September 26, 2017
• Study Start Date: September 2007
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2017)

• Nodule Size [ Time Frame: 3 months ]
  Maximal nodule size measured in centimeters
• Nodule Enhancement [ Time Frame: 3 month ]
  Percent area of nodule with enhancement

• Original Primary Outcome Measures (submitted: October 3, 2007): The primary outcome measurement is agreement of tumor necrosis using triple-phase MultiHance-enhanced MRI, with the percent necrosis seen in patients following surgery or tissue biopsy.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: October 3, 2007): To determine if some combination of the MRI enhancement in the three phases is a better predictor of necrosis compared to enhancement in a single phase.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
• Official Title: Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)
• Brief Summary: This research is being done to find out if using the contrast agent MultiHance can be used to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial Chemoembolization (TACE).

Detailed Description

MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is believed that using MultiHance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve the way patients with hepatocellular carcinoma are managed clinically.

We hypothesize that the Multi-Hance contrast material will provide better image definition of treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast agents.

• Study Type: Interventional
• Study Phase: Not Applicable
• 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)

The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.

Other Name: MultiHance

Study Arms

Gadobenate Dimeglumine (Multi Hance)

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

Intervention: Drug: gadobenate dimeglumine (MultiHance)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 27, 2014): 45
• Original Estimated Enrollment (submitted: October 3, 2007): 25
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Outpatients between the ages of 18 - 80 seen in the cardiovascular and interventional radiology clinic who are scheduled for TACE.
• International Normalized Ratio (INR) <1.4
• Platelet count > 80,000

Exclusion Criteria:

• Contraindications to TACE procedure
• Unable to have an MRI Scan
• Allergy or hypersensitivity reactions to gadolinium or any other ingredients, including benzyl alcohol
• Patients with sickle cell anemia , hemoglobinopathies and other hemolytic anemias
• Known clinical hypersensitivity or a history of asthma or allergic respiratory disorders
• Patients with advanced renal failure (those currently requiring dialysis or with a Glomerular Filtration Rate<15cc/min)
• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00539253
• Other Study ID Numbers: J06108; NA_00003943 ( Other Identifier: Johns Hopkins I.R.B. )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Original Study Sponsor: Same as current
• Collaborators: Bracco Diagnostics, Inc

Investigators

• Principal Investigator: Ihab Kamel; The Johns Hopkins University

• PRS Account: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Verification Date: August 2017