Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
TACE
2 other identifiers
interventional
45
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Sep 2007
Longer than P75 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 2, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
September 26, 2017
CompletedSeptember 26, 2017
August 1, 2017
5.5 years
October 2, 2007
October 12, 2016
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nodule Size
Maximal nodule size measured in centimeters
3 months
Nodule Enhancement
Percent area of nodule with enhancement
3 month
Study Arms (1)
Gadobenate Dimeglumine (Multi Hance)
OTHERIf 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
Interventions
The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ihab R. Kamel, M.D. PhD
- Organization
- Johns Hopkins Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Ihab Kamel
The Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2007
First Posted
October 4, 2007
Study Start
September 1, 2007
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
September 26, 2017
Results First Posted
September 26, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share