Microwave Ablation for Liver Cancer

(ACCLAIM Trial)

Recruiting at 6 trial locations

Overseen By Research Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Society of Interventional Oncology

Disqualifiers: Respiratory distress, Coagulopathy, Allergic reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 27

Duration: 1 day

275 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Microwave Ablation for Liver Cancer?

Research shows that Microwave Thermosphere Ablation (MTA) is effective in treating liver tumors by creating precise areas of destruction, and it has been compared favorably to other methods like radiofrequency ablation for controlling liver metastases. ^{1 2 3 4 5}

Is microwave ablation safe for treating liver cancer?

Microwave ablation (MWA) for liver cancer has been shown to be safe, with a study reporting a 3% rate of minor complications and no deaths within 30 days after the procedure. This suggests that MWA is generally safe for treating liver tumors in humans. ^{1 2 3 4 6}

What makes microwave ablation a unique treatment for liver cancer?

Microwave ablation (MWA) is unique because it uses microwave energy to create heat that destroys liver tumors, and it can create larger and more uniform areas of treatment compared to radiofrequency ablation (RFA), which is another common method. This makes MWA potentially more effective in treating larger tumors or those in difficult-to-reach areas. ^{1 2 3 4 7}

Research Team

Constantinos Sofocleous, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with colorectal cancer that has spread to the liver, with up to 3 small liver tumors (each ≤2.5 cm). Participants can have a few small lung lesions or lymph nodes and must be in good physical condition (ECOG 0-1). They should not have severe illnesses, uncontrolled bleeding disorders, allergies to IV iodine that can't be managed, active infections, or be pregnant.

Inclusion Criteria

I have up to 3 liver tumors, each no larger than 2.5 cm.

I am 18 years old or older.

Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study treatment

Exclusion Criteria

My tumor is close to the central part of my lung.

I cannot lie flat or have trouble breathing when resting.

Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with margin confirmation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for local tumor progression and hepatic disease-free survival

24 months

Multiple visits (in-person and virtual) over 24 months

Margin Assessment

Assessment of the ablation margin is conducted within 7 days post-MWA and again within 4-8 weeks

4-8 weeks

2 visits (in-person)

Treatment Details

Interventions

• Microwave Ablation

Trial Overview The ACCLAIM study tests microwave ablation on small liver metastases from colorectal cancer. The goal is to see if this treatment can stop tumor growth for at least two years in 90% of cases without surgery or other interventions.

Participant Groups

Group I: Microwave ablation with margin confirmation Experimental Treatment 1 Intervention

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.

Microwave Ablation is already approved in United States, European Union for the following indications:

Approved in United States as Microwave Ablation for:

• Colorectal cancer liver metastases
• Unresectable liver lesions
• Small solitary lesions

Approved in European Union as Microwave Ablation for:

• Colorectal cancer liver metastases
• Unresectable liver lesions
• Small solitary lesions

Who Is Running the Clinical Trial?

Society of Interventional Oncology

Lead Sponsor

Trials

3

Recruited

10,000+

Findings from Research

Microwave thermosphere ablation (MTA) demonstrated a remarkable 99.3% complete tumor destruction rate in a study of 53 patients with malignant liver tumors, indicating its high efficacy.

The procedure was safe, with only an 11.3% morbidity rate and no reported mortality, suggesting that MTA is a feasible option for treating liver tumors laparoscopically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic microwave thermosphere ablation of malignant liver tumors: An analysis of 53 cases. Zaidi, N., Okoh, A., Yigitbas, H., et al.[2016]

The study evaluated the safety and efficacy of a new 2.45-GHz thermosphere microwave ablation (MWA) system in 18 patients with malignant liver tumors, showing no morbidity or mortality during the procedure.

At 2 weeks post-ablation, 100% tumor destruction was achieved, with spherical ablation zones confirmed by CT scans, indicating effective treatment of the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic microwave thermosphere ablation of malignant liver tumors: an initial clinical evaluation. Berber, E.[2019]

Microwave thermoablation (MTA) effectively increases tissue temperature in ex-vivo porcine liver, with significant changes in thermal sensitivity observed during both heating and cooling phases, indicating its potential efficacy in destroying hepatic tumors.

The study utilized dual-energy computed tomography (DECT) imaging to assess temperature changes, revealing that higher temperatures correlate with increased ablation-region conspicuity (ARC), which is crucial for evaluating the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual energy computed tomography thermometry during hepatic microwave ablation in an ex-vivo porcine model. Paul, J., Vogl, TJ., Chacko, A.[2016]

Microwave thermosphere ablation (MTA) demonstrated improved local tumor control in patients with colorectal liver metastasis (CRLM), showing a lower local recurrence rate of 10% compared to 20% for radiofrequency ablation (RFA).

MTA also significantly reduced total ablation and operative times (19 minutes for MTA vs. 37 minutes for RFA), while maintaining similar hospital stays and morbidity rates, indicating it may be a more efficient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of microwave thermosphere versus radiofrequency thermal ablation in the treatment of colorectal liver metastases. Takahashi, H., Kahramangil, B., Kose, E., et al.[2019]

In a study of 100 patients undergoing microwave thermosphere ablation for malignant liver tumors, the procedure showed a low local recurrence rate of 6.6% per lesion, indicating effective short-term tumor control.

The study found that tumor size greater than 3 cm and tumor type were significant predictors of local recurrence, with no recurrences observed in patients with neuroendocrine liver metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local recurrence after microwave thermosphere ablation of malignant liver tumors: results of a surgical series. Takahashi, H., Kahramangil, B., Berber, E.[2018]

Microwave ablation (MWA) using the Thermosphere™ Technology demonstrated a high rate of complete tumor ablation (CA) at 93% for percutaneous and 100% for intraoperative procedures in a study of 60 patients with liver malignancies.

The study found that the ablation zones produced by MWA were predictable and aligned with manufacturer predictions based on animal models, indicating that this treatment is both effective and safe across various liver conditions and surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art. De Cobelli, F., Marra, P., Ratti, F., et al.[2018]

Microwave ablation (MWA) significantly reduces local tumor progression (LTP) rates by 30% compared to radiofrequency ablation (RFA), based on a systematic review of 28 studies involving various patient populations.

Both MWA and RFA show similar overall efficacy and safety outcomes for treating liver cancer, indicating that MWA is at least as safe and effective as RFA, with the added benefit of lower LTP rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. Glassberg, MB., Ghosh, S., Clymer, JW., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic microwave thermosphere ablation of malignant liver tumors: An analysis of 53 cases. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic microwave thermosphere ablation of malignant liver tumors: an initial clinical evaluation. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Dual energy computed tomography thermometry during hepatic microwave ablation in an ex-vivo porcine model. [2016]

4. England pubmed.ncbi.nlm.nih.gov

A comparison of microwave thermosphere versus radiofrequency thermal ablation in the treatment of colorectal liver metastases. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Local recurrence after microwave thermosphere ablation of malignant liver tumors: results of a surgical series. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. [2022]