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Trial record 92 of 95 for:    gadobenate dimeglumine

Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

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ClinicalTrials.gov Identifier: NCT00019604
Recruitment Status : Terminated (Principal investigator left the institution.)
First Posted : January 27, 2003
Results First Posted : June 12, 2014
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Cancer
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiofrequency ablation
Procedure: radionuclide imaging
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18 (FDG-PET)
Radiation: gadopentetate dimeglumine
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Period Title: Overall Study
Started 44
Completed 5
Not Completed 39
Reason Not Completed
Death             1
Progressive disease             23
Refused treatment             1
Carcinoid tumor, not treatable             1
Going to have liver transplant             1
Move to a different study             1
Non compliant on systemic CH             1
Non compliant             1
Resectable disease             1
Started new chemo regimen             1
Pt going to immunotherapy study             1
Too much disease             1
Unable to evaluate             1
Details for other not available             4
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  61.4%
>=65 years
17
  38.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
59.18  (13.19)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
21
  47.7%
Male
23
  52.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
44
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
5
  11.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   9.1%
White
35
  79.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
 100.0%
1.Primary Outcome
Title Response
Hide Description Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
Complete Response 0
Partial Response 0
Minor Response 0
Stable Disease 0
Progressive Disease 23
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time Frame 9 years, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Participants
NA [1] 
[1]
Adverse event data is available but the format is uninterpretable.
3.Secondary Outcome
Title Tumor Blood Flow
Hide Description Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.
Time Frame Baseline, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Tumor Vascular Density
Hide Description Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.
Time Frame Baseline, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)
Hide Description Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.
Time Frame Baseline, 6 weeks, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)
Hide Description Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).
Time Frame Baseline, 6 weeks, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies
Hide Description Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.
Time Frame Baseline, 6 weeks, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers
Hide Description Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.
Time Frame Baseline, 6 weeks, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms
Hide Description Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., <median change, >median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).
Time Frame Baseline, 6 weeks, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)
Hide Description PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.
Time Frame Baseline, 6 weeks, 3 months, and 6 months following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description:
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Number zero is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but it is uninterpretable, thus no Serious or Other adverse events are entered for this module.
 
Arm/Group Title Radiofrequency Ablation in Liver Cancer
Hide Arm/Group Description This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
All-Cause Mortality
Radiofrequency Ablation in Liver Cancer
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiofrequency Ablation in Liver Cancer
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiofrequency Ablation in Liver Cancer
Affected / at Risk (%)
Total   0/0 
Adverse event data is available but the format is uninterpretable.
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: Caryn Steakley
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-435-3685
Responsible Party: Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00019604     History of Changes
Obsolete Identifiers: NCT00001795
Other Study ID Numbers: 990025
99-C-0025
CDR0000066875
First Submitted: July 11, 2001
First Posted: January 27, 2003
Results First Submitted: April 1, 2014
Results First Posted: June 12, 2014
Last Update Posted: February 3, 2017