Colorectal Liver MetastasesACCLAIMNCT05265169
Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)
A study testing Microwave ablation in people with Colorectal Liver Metastases, run by Society of Interventional Oncology at 7 sites in 3 countries.
Trial summary
To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastases
- What is being tested?
- Microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 13 Jan 2023to 10 Dec 2027
- 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
- Patient must be at least 18 years old.
- Patient has signed a written informed consent for the MWA and participation in the study.
- Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).
- Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
- Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any lymph node ≤2.0 cm in the largest diameter
- Ability to safely create an ablation zone (AZ) that completely covers the tumor with minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule) or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be included. For these tumors, the calculation of the margin will not apply to the area abutting the capsule or the vessel.
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- The target tumor(s) is/are visible by US and/or CT in a location where MWA is technically achievable and safe based on the proximity to adjacent structures. Protective maneuvers such as hydrodissection for organ mobilization are allowed and will be recorded.
- ECOG performance status of 0-1.
- Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study treatment.
Who cannot join
- Patient is unable to lie flat or has respiratory distress at rest.
- Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
- Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast.
- Patient has evidence of active systemic infection.
- Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
- Patient is currently participating in other experimental studies that could affect the primary endpoint.
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- Patient unable to receive general anesthesia or adequate analgesia and sedation.
- Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts).
- Patient is currently pregnant or intends to become pregnant
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Maria C Briones Dimayuga, MD, 832-792-1692, mcbrione@mdanderson.org
Barom J Aromin, RN, 2817877562, BJAromin@mdanderson.org
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Jenny Camus, 786-527-8151, Juana.Camus@baptisthealth.net
Govindarajan Narayanan, MD
- Recruiting
Medical College of WI
Milwaukee, Wisconsin, 53226
Dawn Carini, 414-955-0212, dcarini@mcw.edu
Amanda Smolock, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Nadia Petree, petree@mskcc.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Desirae Howe-Clayton, 507-255-0111, howe.desirae@mayo.edu
Grant Schmit, MD
Greece1 site, 1 recruiting
- Recruiting
National and Kapodistrian University of Athens (NKUA)
Athens, 12462
Dimitrios K Filippiadis, MD, PhD, dfilippiadis@med.uoa.gr
Dimitrios K Filippiadis, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, 1081
Susan van der Lei, MD, s.vanderlei@amsterdamumc.nl
Martijn Meijerink, MD, PhD
About this study
Official title: Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure
To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
Read the detailed description
In this prospective, multi-center, standard of care trial we propose to establish microwave ablation (MWA) as the preferred curative therapy for selected colorectal liver metastases (CLM) that can be ablated with sufficient margins. Our hypothesis is that MWA of CLM ≤ 2.5 cm with confirmation of ablation margin over 5 mm achieves definitive local tumor control (local cure) with minimal morbidity.
This international study will enroll subjects with one to three CLMs (for a total of 330 tumors/approximately 275 subjects) eligible for local cure using MWA. Any FDA cleared or CE Marked MWA device will be acceptable for use. MWA will be performed with the intent to create a minimum margin of ablation of 5.0 mm and ideally ≥10 mm from the edge of the target tumor to the ablation periphery.
Minimum margin (MM) size will be documented intra-procedurally (immediately post MWA with contrast-enhanced CT) and again within 4-8 weeks after MWA. Assessment of the MM will be conducted by an independent core lab using an FDA approved/cleared image-processing software to provide 3D assessment of the ablation zone and margin.
- The initial assessment of the MM by the core lab will be conducted within 7 days of the MWA and again within 7 days after SOC imaging 4-8 weeks post MWA
- A minimal ablation margin of 5.0 mm will represent the necessary condition for technical success of the ablation.
- Margin assessment will be verified by an independent physician reviewer. For MMs less than 5 mm, repeat MWA will be performed whenever feasible/safe, within 30 days from detection, in order to achieve sufficient MM (> 5mm). Minimum margin size will be correlated with time to local tumor progression. Local disease-free progression (within or abutting the ablation zone) and hepatic disease-free survival (accounting for all tumors ablated) stratified by MM of ≥ 5.0-9.9 mm and ≥ 10.0 mm will be assessed.
- Conditions
- Colorectal Liver Metastases
- Being tested
- Microwave ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationDevice
Microwave ablation of colorectal liver metastases (CLM)
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation with margin confirmation | Experimental | Patients who meet the eligibility criteria will undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with any FDA cleared/CE Marked Microwave Ablation System in accordance with the study site's standard-of-care (SOC) practices. Receives: Device: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor progression free survival at 24 months
See Above
Measured: 24 Months
Secondary outcomes (6)
Hepatic progression free survival by Kaplan-Meier estimate
See Above
Measured: 24 Months
Local tumor progression free survival between sufficient (5.0-9.9 mm) and ideal (≥10 mm) ablation margin categories using Kaplan-Meier methodology and the log-rank test
See Above
Measured: 24 Months
Progression free survival using Kaplan-Meier methodology and the log-rank test
See Above
Measured: 24 Months
Overall and disease specific survival following MWA using Kaplan-Meier methodology
See Above
Measured: 24 Months
Proportion of target tumors treated with an ablation zone (AZ) that completely covers the target tumor(s) with minimal margin (MM) of at least 5 mm
See Above
Measured: 24 Months
Proportion of subjects with CTCAE grade 3 events or greater within 90 days after MWA
See Above
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start13 Jan 2023
- Primary completion11 Nov 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label multicenter trial
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society of Interventional Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265169
- Sponsor's protocol ID
- SIO-2021-01
- Acronym
- ACCLAIM
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sofocleous CT, Callstrom MR, Petre EN, Gonen M, Rilling WS, Ahmed M, Kelekis A, Soulen MC, Pereira P, Crocetti L, Dupuy DE, Solbiati L. Real-time 3D confirmation of complete ablation with margins as a local cure for colorectal liver metastases: the ACCLAIM trial. Trials. 2025 Sep 26;26(1):360. doi: 10.1186/s13063-025-09006-2.
PubMed 41013745
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure
- ClinicalTrials.gov ID
- NCT05265169
- Acronym / sponsor ID
- ACCLAIM / SIO-2021-01
- Conditions
- Colorectal Liver Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Society of Interventional OncologyUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 3 Mar 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.
To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
Detailed description
In this prospective, multi-center, standard of care trial we propose to establish microwave ablation (MWA) as the preferred curative therapy for selected colorectal liver metastases (CLM) that can be ablated with sufficient margins. Our hypothesis is that MWA of CLM ≤ 2.5 cm with confirmation of ablation margin over 5 mm achieves definitive local tumor control (local cure) with minimal morbidity.
This international study will enroll subjects with one to three CLMs (for a total of 330 tumors/approximately 275 subjects) eligible for local cure using MWA. Any FDA cleared or CE Marked MWA device will be acceptable for use. MWA will be performed with the intent to create a minimum margin of ablation of 5.0 mm and ideally ≥10 mm from the edge of the target tumor to the ablation periphery.
Minimum margin (MM) size will be documented intra-procedurally (immediately post MWA with contrast-enhanced CT) and again within 4-8 weeks after MWA. Assessment of the MM will be conducted by an independent core lab using an FDA approved/cleared image-processing software to provide 3D assessment of the ablation zone and margin.
- The initial assessment of the MM by the core lab will be conducted within 7 days of the MWA and again within 7 days after SOC imaging 4-8 weeks post MWA
- A minimal ablation margin of 5.0 mm will represent the necessary condition for technical success of the ablation.
- Margin assessment will be verified by an independent physician reviewer. For MMs less than 5 mm, repeat MWA will be performed whenever feasible/safe, within 30 days from detection, in order to achieve sufficient MM (> 5mm). Minimum margin size will be correlated with time to local tumor progression. Local disease-free progression (within or abutting the ablation zone) and hepatic disease-free survival (accounting for all tumors ablated) stratified by MM of ≥ 5.0-9.9 mm and ≥ 10.0 mm will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation with margin confirmation | Experimental | Device: Microwave ablationPatients who meet the eligibility criteria will undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with any FDA cleared/CE Marked Microwave Ablation System in accordance with the study site's standard-of-care (SOC) practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be at least 18 years old.
- Patient has signed a written informed consent for the MWA and participation in the study.
- Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).
- Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
- Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any lymph node ≤2.0 cm in the largest diameter
Key exclusion criteria (9 listed)
- Patient is unable to lie flat or has respiratory distress at rest.
- Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
- Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast.
- Patient has evidence of active systemic infection.
- Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
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 |
|---|---|---|
| Microwave ablationMicrowave ablation of colorectal liver metastases (CLM) | Device | Microwave ablation with margin confirmation |
Primary outcome
Local tumor progression free survival at 24 months
Time frame: 24 Months
See Above
6 secondary outcomes
Hepatic progression free survival by Kaplan-Meier estimate
Time frame: 24 Months
Local tumor progression free survival between sufficient (5.0-9.9 mm) and ideal (≥10 mm) ablation margin categories using Kaplan-Meier methodology and the log-rank test
Time frame: 24 Months
Progression free survival using Kaplan-Meier methodology and the log-rank test
Time frame: 24 Months
Overall and disease specific survival following MWA using Kaplan-Meier methodology
Time frame: 24 Months
Proportion of target tumors treated with an ablation zone (AZ) that completely covers the target tumor(s) with minimal margin (MM) of at least 5 mm
Time frame: 24 Months
Proportion of subjects with CTCAE grade 3 events or greater within 90 days after MWA
Time frame: 90 Days
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 17 Jan 2024.
- Derived from this study: PubMed 41013745Sofocleous CT, Callstrom MR, Petre EN, Gonen M, Rilling WS, Ahmed M, Kelekis A, Soulen MC, Pereira P, Crocetti L, Dupuy DE, Solbiati L. Real-time 3D confirmation of complete ablation with margins as a local cure for colorectal liver metastases: the ACCLAIM trial. Trials. 2025 Sep 26;26(1):360. doi: 10.1186/s13063-025-09006-2.
- 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.
Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Colorectal Liver Metastases, run by Society of Interventional Oncology at 7 sites in 3 countries.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Greece, Netherlands. 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 Research Manager (202-367-1164, ACCLAIM@SIO-central.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor progression free survival at 24 months (time frame: 24 Months). 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 NCT05265169, which also lists 1 linked publication.
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 17 Jan 2024.