Liver TumorNCT05211388
Treat-and-resect Study of Echo Decorrelation Imaging-controlled Radiofrequency Ablation in Liver Tumors
A study of Liver Tumor, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will comprise the first pilot clinical trial of 3D, ultrasound-based thermal ablation control using echo decorrelation imaging, directly testing the capability of this approach to ensure reliable tumor treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 15 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Scheduled for resection of at least one confirmed primary or metastatic liver tumor with estimated diameter <5 cm at the University of Cincinnati Medical Center (UCMC).
- Patients may have other disease (typically cirrhosis, hepatitis B or hepatitis C) for primary liver cancer patients and extrahepatic cancer (typically colorectal) for metastatic liver cancer patients.
- Ability to understand and the willingness to sign the written research informed consent document for this study.
Who cannot join
- The tumor for which the resection is scheduled is greater than or equal to 5 cm in diameter.
- The tumor for which the resection is scheduled has received: prior ablation; chemoembolization; or, other treatment which in the opinion of the PI would disqualify a patient from participation.
- Radiofrequency ablation (RFA) is contra-indicated for safety reasons in the opinion of the PI and/or clinical treatment team according to current standards of care (e.g., tumor adjacent to the heart, bowel, gall bladder, or bile ducts; impaired liver function; implanted cardiac devices).
- Proceduralist assessment that research-specific radiofrequency ablation or intraoperative ultrasound imaging would cause substantial patient risk.
- Pregnant women, prisoners, institutionalized individuals, or other individuals from vulnerable populations.
- Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
This study will comprise the first pilot clinical trial of 3D, ultrasound-based thermal ablation control using echo decorrelation imaging, directly testing the capability of this approach to ensure reliable tumor treatment. The purpose of this study is to determine the ability of ultrasound echo decorrelation to successfully predict complete ablation of human hepatocellular carcinoma, concomitant diseased liver, and metastatic liver cancer and to determine the potential of echo decorrelation imaging to provide effective real-time control of radiofrequency ablation (RFA) in liver tumors.
Read the detailed description
To rigorously test the feasibility of 3D echo decorrelation imaging to improve the reliability of clinical thermal ablation, decorrelation-controlled ablation will be assessed in a pilot treat-and-resect study. Patients previously scheduled for resection of metastatic liver tumors or benign liver tumors physiologically similar to hepatocellular carcinoma (HCC) (e.g., hepatocellular adenoma or focal nodular hyperplasia) will first undergo radiofrequency ablation (RFA) of their tumors, with real-time, 3D ultrasound echo decorrelation imaging of the treated region performed throughout each ablation. RFA will be performed in the same surgical procedure as the scheduled tumor resection, immediately prior to resection.
Patients will be enrolled in two arms, the first undergoing RFA controlled by the RFA generator using manufacturer-specified algorithms, and the second undergoing RFA with echo decorrelation imaging providing an additional stopping criterion. For both arms, 3D maps of ablation zones will be constructed from stained tissue sections and rigidly registered to volumetric ultrasound images using the known tumor position and orientation relative to the ultrasound image volume. Overall ROC curves for prediction of local treatment will be constructed using point-by-point comparison of 3D echo decorrelation images to the mapped ablation zone.
The ability of echo decorrelation to predict and control clinical thermal ablation of human liver tumors will be directly tested by assessing and statistically comparing outcomes of the two study arms, including ROC curves, ablation volume and rate, and conformity to planned ablation zones.
- Conditions
- Liver Tumor
- Being tested
- RFA controlled using echo decorrelation imaging, RFA controlled using standard manufacturer-specified algorithms
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA controlled using echo decorrelation imagingProcedure or surgery
The tumor will be ablated using standard clinical RFA control algorithms specified by the RFA device manufacturer and implemented on the RFA generator, with echo decorrelation imaging providing an additional stopping criterion.
The targeted ablation zone will be subdivided into one or more contiguous control subvolumes encompassing the tumor. An echo decorrelation threshold will be chosen to provide a target specificity (e.g. 90%) for local ablation prediction, based on ROC curve analysis for ablation prediction in clinical RFA and MWA as well as in controlled ablation of ex vivo human liver tumors. Controlled RFA treatments will proceed until the average cumulative decorrelation exceeds this predetermined threshold within each control subvolume.
To avoid compromising patient safety, treatments will not be extended beyond manufacturer-specified end points.
RFA controlled using standard manufacturer-specified algorithmsProcedure or surgery
The tumor will be ablated using standard clinical RFA control algorithms specified by the RFA device manufacturer and implemented on the RFA generator, e.g. based on temperatures measured by thermocouples integrated into the RFA probe. 3D echo decorrelation imaging will be performed in real time during ablation, but will not be used to modify treatments.
| Study group | Role | What they receive |
|---|---|---|
| arm 1: generator-controlled RFA | Experimental | In up to 6 patients (arm 1: generator-controlled RFA), RFA will be performed directly following manufacturer-specified algorithms, with recording of 3D ultrasound echo decorrelation images during ablation. Receives: Procedure: RFA controlled using standard manufacturer-specified algorithms |
| arm 2: imaging-controlled RFA | Experimental | In up to 6 additional patients (arm 2: imaging-controlled RFA), real-time, 3D echo decorrelation imaging during ablation will provide an additional treatment end point. Receives: Procedure: RFA controlled using echo decorrelation imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curves for local prediction of ablation of human liver tumors and concomitant diseased liver.
Receiver operating characteristic (ROC) curves for prediction of local ablation (dimensionless), constructed using point-by-point comparison of 3D echo decorrelation images to the mapped ablation zone (dimensionless, possible values between 0 and 1). Determined separately for each arm.
Measured: 2 years
Area under ROC curves
Area under ROC curves for prediction of local ablation (dimensionless, possible values between 0 and 1). Determined separately for each arm.
Measured: 2 years
Ablation volumes
Volumes (ml) of segmented ablation zones. Determined separately for each arm.
Measured: 2 years
Thermal ablation rates
Ablation rates (ml/min), defined as ablation volumes (ml) divided by duration of radiofrequency ablation (min). Determined separately for each arm.
Measured: 2 years
Conformity with planned ablation zone
Dice coefficients between segmented ablation volumes and targeted ablation zones (dimensionless, values between 0 and 1). Determined separately for each arm.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start11 Jul 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Why it stopped: Lack of resources to execute study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A total of 12 subjects is anticipated, providing sufficient statistical power for estimation of an overall ROC curve assessing the capability of decorrelation-controlled RFA to reliably ensure complete ablation in human liver tumors, while also providing sufficient power to estimate a separate ROC curve for prediction of local ablation in generator-controlled RFA. The first subjects undergoing the treat-and-resect procedure (at least 2 subjects, or more at discretion of the PI) will be assigned to arm 1 (generator-controlled ablation), and will undergo RFA following manufacturer-specified algorithms. This will allow confirmation of appropriate echo decorrelation thresholds for use as treatment end points. Remaining subjects will be randomly assigned to arm 1 or arm 2 (echo decorrelation imaging-controlled ablation), up to a total of 6 treat-and-resect procedures in each arm.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, T. Douglas Mast, University of Cincinnati
- Investigators
- T. Douglas Mast, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211388
- Sponsor's protocol ID
- UCCC-GI-21-02
- Status last verified
- Aug 2024
- First submitted
- 16 Dec 2021
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat-and-resect Study of Echo Decorrelation Imaging-controlled Radiofrequency Ablation in Liver Tumors
- ClinicalTrials.gov ID
- NCT05211388
- Acronym / sponsor ID
- UCCC-GI-21-02
- Conditions
- Liver Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources to execute study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 27 Jan 2022 (actual)
- 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.
This study will comprise the first pilot clinical trial of 3D, ultrasound-based thermal ablation control using echo decorrelation imaging, directly testing the capability of this approach to ensure reliable tumor treatment. The purpose of this study is to determine the ability of ultrasound echo decorrelation to successfully predict complete ablation of human hepatocellular carcinoma, concomitant diseased liver, and metastatic liver cancer and to determine the potential of echo decorrelation imaging to provide effective real-time control of radiofrequency ablation (RFA) in liver tumors.
Detailed description
To rigorously test the feasibility of 3D echo decorrelation imaging to improve the reliability of clinical thermal ablation, decorrelation-controlled ablation will be assessed in a pilot treat-and-resect study. Patients previously scheduled for resection of metastatic liver tumors or benign liver tumors physiologically similar to hepatocellular carcinoma (HCC) (e.g., hepatocellular adenoma or focal nodular hyperplasia) will first undergo radiofrequency ablation (RFA) of their tumors, with real-time, 3D ultrasound echo decorrelation imaging of the treated region performed throughout each ablation. RFA will be performed in the same surgical procedure as the scheduled tumor resection, immediately prior to resection.
Patients will be enrolled in two arms, the first undergoing RFA controlled by the RFA generator using manufacturer-specified algorithms, and the second undergoing RFA with echo decorrelation imaging providing an additional stopping criterion. For both arms, 3D maps of ablation zones will be constructed from stained tissue sections and rigidly registered to volumetric ultrasound images using the known tumor position and orientation relative to the ultrasound image volume. Overall ROC curves for prediction of local treatment will be constructed using point-by-point comparison of 3D echo decorrelation images to the mapped ablation zone.
The ability of echo decorrelation to predict and control clinical thermal ablation of human liver tumors will be directly tested by assessing and statistically comparing outcomes of the two study arms, including ROC curves, ablation volume and rate, and conformity to planned ablation zones.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 12 subjects is anticipated, providing sufficient statistical power for estimation of an overall ROC curve assessing the capability of decorrelation-controlled RFA to reliably ensure complete ablation in human liver tumors, while also providing sufficient power to estimate a separate ROC curve for prediction of local ablation in generator-controlled RFA. The first subjects undergoing the treat-and-resect procedure (at least 2 subjects, or more at discretion of the PI) will be assigned to arm 1 (generator-controlled ablation), and will undergo RFA following manufacturer-specified algorithms. This will allow confirmation of appropriate echo decorrelation thresholds for use as treatment end points. Remaining subjects will be randomly assigned to arm 1 or arm 2 (echo decorrelation imaging-controlled ablation), up to a total of 6 treat-and-resect procedures in each arm.
| Arm | Type | Receives |
|---|---|---|
| arm 1: generator-controlled RFA | Experimental | Procedure: RFA controlled using standard manufacturer-specified algorithmsIn up to 6 patients (arm 1: generator-controlled RFA), RFA will be performed directly following manufacturer-specified algorithms, with recording of 3D ultrasound echo decorrelation images during ablation. |
| arm 2: imaging-controlled RFA | Experimental | Procedure: RFA controlled using echo decorrelation imagingIn up to 6 additional patients (arm 2: imaging-controlled RFA), real-time, 3D echo decorrelation imaging during ablation will provide an additional treatment end point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Scheduled for resection of at least one confirmed primary or metastatic liver tumor with estimated diameter <5 cm at the University of Cincinnati Medical Center (UCMC).
- Patients may have other disease (typically cirrhosis, hepatitis B or hepatitis C) for primary liver cancer patients and extrahepatic cancer (typically colorectal) for metastatic liver cancer patients.
- Ability to understand and the willingness to sign the written research informed consent document for this study.
Key exclusion criteria (6 listed)
- The tumor for which the resection is scheduled is greater than or equal to 5 cm in diameter.
- The tumor for which the resection is scheduled has received: prior ablation; chemoembolization; or, other treatment which in the opinion of the PI would disqualify a patient from participation.
- Radiofrequency ablation (RFA) is contra-indicated for safety reasons in the opinion of the PI and/or clinical treatment team according to current standards of care (e.g., tumor adjacent to the heart, bowel, gall bladder, or bile ducts; impaired liver function; implanted cardiac devices).
- Proceduralist assessment that research-specific radiofrequency ablation or intraoperative ultrasound imaging would cause substantial patient risk.
- Pregnant women, prisoners, institutionalized individuals, or other individuals from vulnerable populations.
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 |
|---|---|---|
| RFA controlled using echo decorrelation imagingThe tumor will be ablated using standard clinical RFA control algorithms specified by the RFA device manufacturer and implemented on the RFA generator, with echo decorrelation imaging providing an additional stopping criterion. The targeted ablation zone will be subdivided into one or more contiguous control subvolumes encompassing the tumor. An echo decorrelation threshold will be chosen to provide a target specificity (e.g. 90%) for local ablation prediction, based on ROC curve analysis for ablation prediction in clinical RFA and MWA as well as in controlled ablation of ex vivo human liver tumors. Controlled RFA treatments will proceed until the average cumulative decorrelation exceeds this predetermined threshold within each control subvolume. To avoid compromising patient safety, treatments will not be extended beyond manufacturer-specified end points. | Procedure or surgery | arm 2: imaging-controlled RFA |
| RFA controlled using standard manufacturer-specified algorithmsThe tumor will be ablated using standard clinical RFA control algorithms specified by the RFA device manufacturer and implemented on the RFA generator, e.g. based on temperatures measured by thermocouples integrated into the RFA probe. 3D echo decorrelation imaging will be performed in real time during ablation, but will not be used to modify treatments. | Procedure or surgery | arm 1: generator-controlled RFA |
Primary outcome
ROC curves for local prediction of ablation of human liver tumors and concomitant diseased liver.
Time frame: 2 years
Receiver operating characteristic (ROC) curves for prediction of local ablation (dimensionless), constructed using point-by-point comparison of 3D echo decorrelation images to the mapped ablation zone (dimensionless, possible values between 0 and 1). Determined separately for each arm.
Area under ROC curves
Time frame: 2 years
Area under ROC curves for prediction of local ablation (dimensionless, possible values between 0 and 1). Determined separately for each arm.
Ablation volumes
Time frame: 2 years
Volumes (ml) of segmented ablation zones. Determined separately for each arm.
Thermal ablation rates
Time frame: 2 years
Ablation rates (ml/min), defined as ablation volumes (ml) divided by duration of radiofrequency ablation (min). Determined separately for each arm.
Conformity with planned ablation zone
Time frame: 2 years
Dice coefficients between segmented ablation volumes and targeted ablation zones (dimensionless, values between 0 and 1). Determined separately for each arm.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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.
T. Douglas Mast, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Liver Tumor, run by University of Cincinnati 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
ROC curves for local prediction of ablation of human liver tumors and concomitant diseased liver. (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2024.