Clinical trial · Interventional
Study of New Software Used During Ablations
Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: * Participants will be screened with a medical history. * Participants will visit the clinic for their already-scheduled ablation. The doctor will use the study software to 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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Cancer | — | UNRESOLVED | — |
| Hepatic Neoplasms | Liver Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasms, Liver | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablation Probe | Procedure | — | UNRESOLVED |
| CT/CBCT thermometry method | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements
- interventionNames
- Procedure: CT/CBCT thermometry method
- Procedure: Ablation Probe
Primary outcomes (1)
- measure
- To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method
- timeFrame
- two years
- description
- Bayesian median estimate will be used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Subjects must be scheduled for a hepatic radiofrequency or microwave ablation in interventional radiology requiring thermocouples for temperature monitoring. Any patient undergoing a hepatic radiofrequency or microwave ablation could be eligible for this protocol. * Must be age 18 years or older. EXCLUSION CRITERIA: * Subjects have an altered mental status precluding understanding or consenting to the procedure * Subjects have a body weight in excess of 375 lbs. * Subject is pregnant
References
Publications (3)
- BACKGROUNDCho 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. PMID 21679247
- BACKGROUNDDodd 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. PMID 11566672
- BACKGROUNDLencioni 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. PMID 18304832