Carcinoma, HepatocellularNCT04970212
Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
An observational study of Carcinoma, Hepatocellular and Metastatic Liver Cancer, run by Techsomed Medical Technologies LTD at 6 sites in United States.
Trial summary
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Metastatic Liver Cancer
- What is being tested?
- BioTraceIO Lite
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Sep 2021to 8 Oct 2022
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have been scheduled to have a liver ablation as part of their clinical care.
Who may be able to join
- Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy.
- At least 21 years of age
- Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
- Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
- Single ablation, using a single ablation needle, per tumor.
- Able and willing to give informed consent.
Who cannot join
- Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
- Subject cannot tolerate/undergo contrast-enhanced CT.
- Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.
- Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
- Pregnant or lactating
- Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
- Unable or unwilling to give informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals Cleveland
Cleveland, Ohio, 44106
Houston Methodist Hospital
Houston, Texas, 77030
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Stanford Medicine
Stanford, California, 94305
About this study
Official title: Pivotal Clinical Study to Establish the Safety and Effectiveness of the Use of BioTraceIO Lite for Assessment of Tissue Damage Following Liver Tissue Ablation Procedures
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events.
Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Read the detailed description
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.
BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
- Conditions
- Carcinoma, Hepatocellular, Metastatic Liver Cancer
- Being tested
- BioTraceIO Lite
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioTraceIO LiteDevice
The BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Subjects will receive your standard liver ablation procedure, including ultrasound images. Data will be collected from the standard liver ablation procedure, including imaging. Subjects will receive a CT scan within 24 hours after the liver ablation procedure. There will then be an analysis of ultrasound images and research CT scan. Receives: Device: BioTraceIO Lite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events
Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.
Measured: 1 year
Effectiveness - DICE
Paired comparison of the DICE similarity coefficient, assessed between BioTraceIO Lite, as measured at end of ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24), and the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure CECT (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24).
Measured: 1 year
Secondary outcomes (4)
Sensitivity
Sensitivity of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.
Measured: 1 year
Precision
Precision of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.
Measured: 1 year
Questionnaire - Effect of BioTraceIO
The proportion of subjects in whom the treating physician indicates that, if the BioTraceIO Lite results had been available for use in patient management, it would have impacted their follow-up plan for patient management, compared to the CECT alone.
Measured: 1 year
Difference between T=0 and T=24hrs CECT tissue damage
Difference in percentage between tissue damage volume as visualized at T=0 contrast-enhanced computed tomography (CECT) versus tissue damage volume as visualized at T=24hrs CECT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start24 Sep 2021
- Primary completion8 Oct 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Techsomed Medical Technologies LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970212
- Sponsor's protocol ID
- CL000012
- Status last verified
- Apr 2023
- First submitted
- 5 Jul 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Clinical Study to Establish the Safety and Effectiveness of the Use of BioTraceIO Lite for Assessment of Tissue Damage Following Liver Tissue Ablation Procedures
- ClinicalTrials.gov ID
- NCT04970212
- Acronym / sponsor ID
- CL000012
- Conditions
- Carcinoma, Hepatocellular, Metastatic Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Techsomed Medical Technologies LTDIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 21 Jul 2021 (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.
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events.
Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Detailed description
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.
BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | – | Device: BioTraceIO LiteSubjects will receive your standard liver ablation procedure, including ultrasound images. Data will be collected from the standard liver ablation procedure, including imaging. Subjects will receive a CT scan within 24 hours after the liver ablation procedure. There will then be an analysis of ultrasound images and research CT scan. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been scheduled to have a liver ablation as part of their clinical care.
Key inclusion criteria (6 listed)
- Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy.
- At least 21 years of age
- Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
- Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
- Single ablation, using a single ablation needle, per tumor.
Key exclusion criteria (7 listed)
- Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
- Subject cannot tolerate/undergo contrast-enhanced CT.
- Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.
- Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
- Pregnant or lactating
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 |
|---|---|---|
| BioTraceIO LiteThe BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map. | Device | Study Arm |
Primary outcome
Safety - Adverse Events
Time frame: 1 year
Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.
Effectiveness - DICE
Time frame: 1 year
Paired comparison of the DICE similarity coefficient, assessed between BioTraceIO Lite, as measured at end of ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24), and the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure CECT (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24).
4 secondary outcomes
Sensitivity
Time frame: 1 year
Precision
Time frame: 1 year
Questionnaire - Effect of BioTraceIO
Time frame: 1 year
Difference between T=0 and T=24hrs CECT tissue damage
Time frame: 1 year
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 18 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular and Metastatic Liver Cancer, run by Techsomed Medical Technologies LTD at 6 sites 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 6 inclusion and 7 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Safety - Adverse Events (time frame: 1 year). The study lists 2 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 18 Apr 2023.