Ablation for Liver Cancer

Overseen By Constantinos Sofocleous, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Age < 18, More than 3 tumors, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new test to determine if a liver tumor ablation treatment has been successful. CT-guided percutaneous ablation uses heat or cold to destroy cancer cells, but a CT scan alone cannot confirm if all cancer cells are gone. The test under study aims to help doctors identify whether any cancer cells remain or if the area is healing normally. Suitable candidates for this trial have secondary liver cancer, stable disease, and prefer non-surgical treatment options. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on Coumadin, general clinical guidelines for IR ablation will be followed, which might involve adjustments.

What prior data suggests that CT guided percutaneous ablation is safe for liver cancer treatment?

Research shows that CT-guided percutaneous ablation is generally safe for treating liver cancer. One study found it to be a safe and effective option, particularly as a less invasive alternative to surgery. In another study, all patients successfully underwent the procedure, and only 32.2% experienced tumor growth in the treated area over an average follow-up of 18.5 months. This indicates that patients generally tolerate the treatment well.

Although some patients experienced tumor growth after treatment, the body usually tolerates the procedure well. Overall, CT-guided ablation is considered a reliable and safe method for addressing liver tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CT guided percutaneous ablation for liver cancer because it offers a targeted and minimally invasive approach. Unlike traditional surgeries or systemic treatments like chemotherapy, this technique uses imaging guidance to precisely apply heat or cold to destroy cancer cells directly in the liver. This precision helps to preserve healthy liver tissue and reduces overall recovery time. Additionally, the method allows for the use of specialized electrodes, such as multi-tined or internally cooled needles, which can be selected based on the tumor's location to minimize harm to surrounding vital structures. This tailored approach can make treatment more effective and safer for patients.

What evidence suggests that CT guided percutaneous ablation is effective for liver cancer?

Research has shown that using CT scans to guide a needle for destroying liver tumors is quite effective. In this trial, participants will undergo CT-guided percutaneous ablation. Studies have found that this method successfully removes tumors in about 82% to 84% of cases, even when the tumor is in a difficult-to-reach area. One study found that patients with tumors 3 cm or smaller had survival rates similar to those who underwent surgery. Follow-ups revealed that about 32% of patients experienced tumor regrowth in the same spot, highlighting the importance of regular check-ups after treatment. Overall, CT-guided ablation is a promising option for liver cancer, especially when surgery isn't possible. ^{1 3 5 6 7}

Who Is on the Research Team?

Constantinos Sofocleous, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with liver tumors no larger than 5cm, who aren't surgical candidates or prefer not to have surgery. They should have a stable blood clotting measure (INR<1.5), enough platelets, and either confined liver disease or limited stable disease outside the liver.

Inclusion Criteria

Platelet count >= 50,000

I have been diagnosed with cancer that has spread to my liver.

My cancer is mainly in my liver or is stable and not widely spread.

Exclusion Criteria

I am under 18 years old.

My tumor is very close to a large blood vessel.

My tumor is very close to a vital organ and cannot be safely treated with certain techniques.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo CT guided percutaneous ablation to treat malignant liver metastases

1 day

1 visit (in-person)

Follow-up

Participants are monitored for tumor response and progression using CT scans and other criteria

3 years

Regular follow-up visits with CT scans

What Are the Treatments Tested in This Trial?

Interventions

• CT guided percutaneous ablation

Trial Overview The study tests if analyzing tissue from ablated malignant liver metastases can predict treatment success. It involves CT-guided percutaneous ablation—a minimally invasive procedure—and examines whether new growths are cancerous post-treatment.

How Is the Trial Designed?

Group I: CT guided percutaneous ablation Experimental Treatment 1 Intervention

The selected patients will undergo CT guided percutaneous ablation. The use of multi-tined electrode is encouraged, unless tumor location requires the use of an internally cooled needle electrode to eliminate injury to an adjacent vital structure or the operator prefers to use an internally cooled electrode for a specific reason.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Rockefeller University

Collaborator

Trials

162

Recruited

16,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6402784/

Comparative Effectiveness of CT- vs. Ultrasound-Guided ... However, approximately 80–90% of HCC patients were diagnosed at the stage that is too late to benefit from the potentially curative surgical ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1076633224002344

Efficacy and Safety of CT-guided Percutaneous ... Follow-up ranged from 24 to 38 months. The complete ablation rate was 82.1% and 71.7% in the high-risk group and 83.9% and 73.9% in the non-high-risk group ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12025409/

Surgery or Percutaneous Ablation for Liver Tumors? The Key ... Recent comparisons between liver resection (LR) and percutaneous thermal ablation (PTA) reported similar survival outcomes for tumors ≤ 3 cm in size.

4. nature.com nature.com/articles/s41598-023-43516-w

Long-term outcome and eligibility of radiofrequency ... Among all patients, 77 patients achieved complete ablation in one session. There were no treatment-related deaths or major complications. Local ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2019.1684575

Full article: Efficacy and safety of CT-guided percutaneous ... Technical success was achieved for all tumors. In the median follow-up of 18.5 months, local tumor progression occurred in 32.2% (19/59) of patients, while ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9556503/

CT-guided percutaneous chemical ablation combined with ... The efficacy and safety were compared between the two groups. 41 patients had 51 lesions in high-risk locations, including 24 cases with 30 lesions in PLI+RFA ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7716003/

Efficacy and safety of percutaneous microwave ablation for ... Forty-four out of 53 HCCs in difficult location group and 44 out of 48 HCCs in control group showed complete response at first follow-up imaging study with ...