Liver CancerNCT01906021
Study of New Software Used During Ablations
A study testing CT/CBCT thermometry method and Ablation Probe in people with Liver Cancer and Neoplasms, Liver, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Cancer, Neoplasms, Liver, Hepatic Neoplasms
- What is being tested?
- CT/CBCT thermometry method and Ablation Probe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2013to 8 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations
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.
Read more
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.
Read the detailed description
Background:
- Lack of reliable non-invasive method to monitor ablation zone during radiofrequency or microwave ablation
- Development of a non-invasive technique to examine temperature changes based on changes in CT or CBCT attenuation
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:
- An altered mental status precluding understanding or consenting for the procedure
- A gross body weight exceeding 375 pounds (upper limit of angio table)
- A pregnancy
Design:
- Number of participants: 16
- Number of sites: 1
- Recruitment time frame: 2 years
- Type of study: pilot study to validate an image analysis thermometry technique
- Patients undergoing clinically indicated hepatic ablations are eligible for this protocol. As part of this study, one to two additional research scans of the liver may be acquired during the ablation and analyzed separately with our software and compared with thermocouple measurements. There will be no changes in devices, probes or additional probe manipulations as part of this study. The operator will not modify the procedure based on results of this software.
- Conditions
- Liver Cancer, Neoplasms, Liver, Hepatic Neoplasms, Hepatic Cancer
- Being tested
- CT/CBCT thermometry method, Ablation Probe
- Keywords
- Thermomap, Hepatic Lesions, Radiofrequency Ablation, Microwave, Non-Invasive Technique
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT/CBCT thermometry methodProcedure or surgery
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
Ablation ProbeProcedure or surgery
Temperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements Receives: Procedure: CT/CBCT thermometry method; Procedure: Ablation Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study start23 Sep 2013
- Primary completion1 Aug 2015
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bradford J Wood, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906021
- Sponsor's protocol ID
- 130178
- Other IDs
- 13-CC-0178
- Status last verified
- Dec 2020
- First submitted
- 19 Jul 2013
- Last updated
- 10 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21679247Dodd 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.
PubMed 11566672Lencioni 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.
PubMed 18304832
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Observational Study Examining Cone Beam CT and CT Thermometry During Ablations
- ClinicalTrials.gov ID
- NCT01906021
- Acronym / sponsor ID
- 130178
- Conditions
- Liver Cancer, Neoplasms, Liver, Hepatic Neoplasms, Hepatic Cancer
- Keywords
- Thermomap, Hepatic Lesions, Radiofrequency Ablation, Microwave, Non-Invasive Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 23 Sep 2013 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
- Lack of reliable non-invasive method to monitor ablation zone during radiofrequency or microwave ablation
- Development of a non-invasive technique to examine temperature changes based on changes in CT or CBCT attenuation
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:
- An altered mental status precluding understanding or consenting for the procedure
- A gross body weight exceeding 375 pounds (upper limit of angio table)
- A pregnancy
Design:
- Number of participants: 16
- Number of sites: 1
- Recruitment time frame: 2 years
- Type of study: pilot study to validate an image analysis thermometry technique
- Patients undergoing clinically indicated hepatic ablations are eligible for this protocol. As part of this study, one to two additional research scans of the liver may be acquired during the ablation and analyzed separately with our software and compared with thermocouple measurements. There will be no changes in devices, probes or additional probe manipulations as part of this study. The operator will not modify the procedure based on results of this software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: CT/CBCT thermometry method, Procedure: Ablation ProbeIntra-patient comparison of temperature map obtained during CT/CBCT with standard ablation temperature measurements |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT/CBCT thermometry methodThe 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 | Procedure or surgery | 1 |
| Ablation ProbeTemperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern) | Procedure or surgery | 1 |
Primary outcome
To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method
Time frame: two years
Bayesian median estimate will be used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Background: PubMed 21679247Cho 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.
- Background: PubMed 11566672Dodd 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.
- Background: PubMed 18304832Lencioni 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford J Wood, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT/CBCT thermometry method and Ablation Probe in people with Liver Cancer and Neoplasms, Liver, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure accuracy of temperature monitoring using non-invasive thermomap (temperature imaging profile) method compared to the currently accepted invasive thermocouples method (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906021, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.