| ID | Type | Description | Link |
|---|---|---|---|
| 99-C-0025 | |||
| CDR0000066875 |
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Principal investigator left the institution.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.
OBJECTIVES:
OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment.
Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation in liver cancer | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography | Procedure | Scan to assess the effects of ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | 9 years, 9 months |
| Tumor Blood Flow |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary or metastatic liver lesions
Must have six or fewer lesions and no single lesion greater than 7 cm in diameter
Extrahepatic disease allowed
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A Libutti, MD | National Cancer Institute, National Institutes of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | 20892-1182 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Ablation in Liver Cancer | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| magnetic resonance imaging | Procedure | Imaging used to assess the effects of this ablative therapy on tumor vascular density. |
|
| positron emission tomography | Procedure | Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues. |
|
| radiofrequency ablation | Procedure | Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization. |
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| radionuclide imaging | Procedure | Imaging following injection of a radioactive material. |
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| ultrasound imaging | Procedure | An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement. |
|
| fludeoxyglucose F 18 (FDG-PET) | Radiation | FDG PET scans rely on metabolic changes to evaluate response to therapy. |
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| gadopentetate dimeglumine | Radiation | Food and Drug Administration approved contrast agent. |
|
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.
| Baseline, 3 months, and 6 months following treatment |
| Tumor Vascular Density | 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. | Baseline, 3 months, and 6 months following treatment |
| Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA) | 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. | Baseline, 6 weeks, 3 months, and 6 months following treatment |
| Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT) | 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). | Baseline, 6 weeks, 3 months, and 6 months following treatment |
| Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies | 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. | Baseline, 6 weeks, 3 months, and 6 months following treatment |
| Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers | 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. | Baseline, 6 weeks, 3 months, and 6 months following treatment |
| 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 | 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). | Baseline, 6 weeks, 3 months, and 6 months following treatment |
| Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA) | 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. | Baseline, 6 weeks, 3 months, and 6 months following treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Ablation in Liver Cancer | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Response | 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. | 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. | Posted | Number | Participants |
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| Secondary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | 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. | Posted | Number | Participants | 9 years, 9 months |
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| Secondary | Tumor Blood Flow | 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. | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 3 months, and 6 months following treatment |
|
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| Secondary | Tumor Vascular Density | 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. | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 3 months, and 6 months following treatment |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA) | 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. | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 6 weeks, 3 months, and 6 months following treatment |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT) | 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). | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 6 weeks, 3 months, and 6 months following treatment |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies | 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. | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 6 weeks, 3 months, and 6 months following treatment |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers | 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. | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 6 weeks, 3 months, and 6 months following treatment |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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). | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 6 weeks, 3 months, and 6 months following treatment |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA) | 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. | This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study. | Posted | Baseline, 6 weeks, 3 months, and 6 months following treatment |
|
|
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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.
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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 | Radiofrequency Ablation in Liver Cancer | 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. | 0 | 0 | 0 | 0 |
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Adverse event data is available but the format is uninterpretable.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caryn Steakley | National Cancer Institute, National Institutes of Health | 301-435-3685 | steaklec@mail.nih.gov |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D000078703 | Radiofrequency Ablation |
| D019220 | High-Energy Shock Waves |
| D019788 | Fluorodeoxyglucose F18 |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Stable Disease |
|
| Progressive Disease |
|
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| Participants |
|