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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00003943 | Other Identifier | Johns Hopkins I.R.B. |
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| Name | Class |
|---|---|
| Bracco Diagnostics, Inc | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gadobenate dimeglumine (MultiHance) | Drug | The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nodule Size | Maximal nodule size measured in centimeters | 3 months |
| Nodule Enhancement | Percent area of nodule with enhancement | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ihab Kamel | The Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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none observed
January, 2008 to May, 2012
People with hepatocellular carcinoma who were candidates for TACE who were referred to Johns Hopkins Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadabenate 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 gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MRI imaging for both the baseline and 1 month f/u studies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nodule Size | Maximal nodule size measured in centimeters | The number of participants analyzed reflects the number of participants for whom data was available. | Posted | Mean | Standard Deviation | centimeters | 3 months |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ihab R. Kamel, M.D. PhD | Johns Hopkins Hospital | 410-955-4567 | ikamel@jhmi.edu |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C064572 | gadobenic acid |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Percentage of enhancement changes observed using Triple-phase MultiHance-enhanced MRI | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Nodule Enhancement | Percent area of nodule with enhancement | Number of participants analyzed reflects the number of participants for whom data was available | Posted | Mean | Standard Deviation | percent enhancement | 3 month |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
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| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |