Hepatocellular CarcinomaTACENCT00539253
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
A study testing gadobenate dimeglumine (MultiHance) in people with Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- gadobenate dimeglumine (MultiHance)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)
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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- gadobenate dimeglumine (MultiHance)
- Keywords
- liver cancer, transarterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadobenate dimeglumine (MultiHance)Drug
Also called MultiHance
The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
| Study group | Role | What they receive |
|---|---|---|
| Gadobenate Dimeglumine (Multi Hance) | Other | 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 Receives: Drug: gadobenate dimeglumine (MultiHance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodule Size
Maximal nodule size measured in centimeters
Measured: 3 months
Nodule Enhancement
Percent area of nodule with enhancement
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Ihab Kamel, Principal investigator, The Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539253
- Sponsor's protocol ID
- J06108
- Other IDs
- NA_00003943
- Acronym
- TACE
- Status last verified
- Aug 2017
- First submitted
- 2 Oct 2007
- Last updated
- 26 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT00539253
- Acronym / sponsor ID
- TACE / J06108
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer, transarterial chemoembolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bracco Diagnostics, Inc
- Study start
- Sep 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Posted 26 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadobenate Dimeglumine (Multi Hance) | Other | Drug: gadobenate dimeglumine (MultiHance)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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gadobenate dimeglumine (MultiHance)Also: MultiHanceThe contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies. | Drug | Gadobenate Dimeglumine (Multi Hance) |
Primary outcome
Nodule Size
Time frame: 3 months
Maximal nodule size measured in centimeters
Nodule Enhancement
Time frame: 3 month
Percent area of nodule with enhancement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihab Kamel principal investigator
The Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gadobenate dimeglumine (MultiHance) in people with Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodule Size (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.