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| ID | Type | Description | Link |
|---|---|---|---|
| 13-CC-0178 |
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Background:
- Ablation is a procedure that heats tumor tissue to a high temperature to destroy it. Doctors perform this procedure by putting a probe in the tumor. This delivers heat to the site. Currently, doctors tell what area is heated by using the probe s manufacturer estimates. These estimates are imprecise. Doctors insert small needles to measure the temperature around the area being heated. Doctors also perform scans of the area, but these cannot show which tissue has been heated and which has not. Right now, only contrast scans can show that. But researchers have developed software that uses images from routine scans to create a temperature map. They want to test the software to see if doctors can monitor the procedure without using more needles and without contrast scans.
Objectives:
- To test software that might help doctors perform ablations better in the future.
Eligibility:
- People over 18 years of age already scheduled to have an ablation.
Design:
analyze the temperature in the area being heated. The software will not come into contact with a participant s body.
- Participants will undergo scans that are necessary for the procedure, but one or two additional scans may be done as part of this study.
Background:
Objectives:
-To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method.
Eligibility:
Subjects are eligible if:
--They are scheduled in interventional radiology for hepatic radiofrequency or microwave ablation requiring thermocouples for monitoring
Subjects are excluded if they have:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT/CBCT thermometry method | Procedure | The study consists of acquiring one or maximum two additional CT or CBCT of the liver during hepatic RFA or MWA and analyzing the images to obtain a temperature map |
| Measure | Description | Time Frame |
|---|---|---|
| To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method | Bayesian median estimate will be used. | two years |
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EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Bradford J Wood, M.D. | National Institutes of Health Clinical Center (CC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21679247 | Background | Cho YK, Rhim H, Noh S. Radiofrequency ablation versus surgical resection as primary treatment of hepatocellular carcinoma meeting the Milan criteria: a systematic review. J Gastroenterol Hepatol. 2011 Sep;26(9):1354-60. doi: 10.1111/j.1440-1746.2011.06812.x. | |
| 11566672 | Background | Dodd GD 3rd, Frank MS, Aribandi M, Chopra S, Chintapalli KN. Radiofrequency thermal ablation: computer analysis of the size of the thermal injury created by overlapping ablations. AJR Am J Roentgenol. 2001 Oct;177(4):777-82. doi: 10.2214/ajr.177.4.1770777. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Ablation Probe | Procedure | Temperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern) |
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| 18304832 | Background | Lencioni R, Crocetti L. Image-guided thermal ablation of hepatocellular carcinoma. Crit Rev Oncol Hematol. 2008 Jun;66(3):200-7. doi: 10.1016/j.critrevonc.2008.01.003. Epub 2008 Mar 4. |
| D008107 |
| Liver Diseases |