Liver TumorsNCT07877220
Estimating The Rate Of Complete Ablation (A0) With The Use Of Biomechanical Deformable Image Registration
A study testing RayAblation in people with Liver Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to find out if using an updated version of standard computer software (called RayStation) for confirming that thermal ablation treatment was able to destroy all tumor cells including a safety margin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumors
- What is being tested?
- RayAblation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with primary or secondary liver tumors referred for percutaneous thermal liver ablation as per the standard of care
- ≤5 abatable tumors
- Each tumor measuring ≤5 cm in its largest dimension
- Ability to obtain a 5 mm MAM on pre- and intraprocedural CECT
Who cannot join
- Age <18 years old
- Currently breastfeeding or pregnant
- Unable to receive at least pre- and final post-ablation contrast-enhanced CT during the ablation procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Iwan Paolucci, PHD, 713-792-1846, ipaolucci@mdanderson.org
Iwan Paolucci, PHD
About this study
The goal of this research study is to find out if using an updated version of standard computer software (called RayStation) for confirming that thermal ablation treatment was able to destroy all tumor cells including a safety margin.
Read the detailed description
Primary Objective:
- To estimate the A0 rate (≥5mm MAM) after percutaneous thermal ablation of malignant liver tumors achieved when using RayAblation intra-procedurally
Secondary Objectives:
- To evaluate the usability by the treating interventional radiologist on a System Usability Score questionnaire
- To evaluate the performance of the segmentation and registration algorithms within RayAblation
- To evaluate the complication rates related to the use of RayAblation .
- Conditions
- Liver Tumors
- Being tested
- RayAblation
- Keywords
- Thermal Ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RayAblationDevice
AC software will be used at the end of the procedure to assess the ablation margins.
| Study group | Role | What they receive |
|---|---|---|
| Patients treatment with RayAblation | Experimental | Participants will undergo standard-of-care thermal ablation as per institutional practice Receives: Device: RayAblation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- RaySearch Laboratories
- Responsible party
- Sponsor
- Investigators
- Iwan Paolucci, PHD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877220
- Sponsor's protocol ID
- 2026-0543
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating The Rate Of Complete Ablation (A0) With The Use Of Biomechanical Deformable Image Registration
- ClinicalTrials.gov ID
- NCT07877220
- Acronym / sponsor ID
- 2026-0543
- Conditions
- Liver Tumors
- Keywords
- Thermal Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- RaySearch Laboratories
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Oct 2026 (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.
The goal of this research study is to find out if using an updated version of standard computer software (called RayStation) for confirming that thermal ablation treatment was able to destroy all tumor cells including a safety margin.
Detailed description
Primary Objective:
- To estimate the A0 rate (≥5mm MAM) after percutaneous thermal ablation of malignant liver tumors achieved when using RayAblation intra-procedurally
Secondary Objectives:
- To evaluate the usability by the treating interventional radiologist on a System Usability Score questionnaire
- To evaluate the performance of the segmentation and registration algorithms within RayAblation
- To evaluate the complication rates related to the use of RayAblation .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treatment with RayAblation | Experimental | Device: RayAblationParticipants will undergo standard-of-care thermal ablation as per institutional practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with primary or secondary liver tumors referred for percutaneous thermal liver ablation as per the standard of care
- ≤5 abatable tumors
- Each tumor measuring ≤5 cm in its largest dimension
- Ability to obtain a 5 mm MAM on pre- and intraprocedural CECT
Key exclusion criteria (3 listed)
- Age <18 years old
- Currently breastfeeding or pregnant
- Unable to receive at least pre- and final post-ablation contrast-enhanced CT during the ablation procedure
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 |
|---|---|---|
| RayAblationAC software will be used at the end of the procedure to assess the ablation margins. | Device | Patients treatment with RayAblation |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- UT MD Anderson WebsiteLink 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.
Iwan Paolucci, PHD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RayAblation in people with Liver Tumors, run by M.D. Anderson Cancer Center 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 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwan Paolucci, PHD ((713) 792-1846, ipaolucci@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 16 Oct 2026.