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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CT guided percutaneous ablation for liver cancer?

Research shows that percutaneous image-guided tumor ablation, including CT-guided methods, is a valuable and effective treatment for liver tumors. It is minimally invasive, has a low complication rate, and is effective in improving local progression-free survival. ^{1 2 3 4 5}

Is ablation for liver cancer generally safe for humans?

Ablation treatments for liver cancer, like cryoablation, radiofrequency ablation, and microwave ablation, are generally considered safe with rare major complications. However, there can be side effects, such as non-target thermal injury and vascular complications, so it's important for doctors to be aware of these to minimize risks. ^{6 7 8 9 10}

How is CT guided percutaneous ablation unique for liver cancer treatment?

CT guided percutaneous ablation is unique because it uses imaging technology to precisely target and destroy liver tumors with minimal invasiveness, allowing for accurate needle placement and real-time monitoring during the procedure. This method is particularly beneficial for patients with tumors that cannot be surgically removed, offering a less invasive alternative with potentially fewer complications. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked. The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.

Research Team

Constantinos Sofocleous, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

I have had more than 3 tumors treated without surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. India pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided microwave ablation of hepatic malignancies: Feasibility, efficacy, safety, and follow-up. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Percutaneous CT-guided radiofrequency ablation for patients with extrahepatic oligometastases of hepatocellular carcinoma: long-term results. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Current use of percutaneous image-guided tumor ablation for the therapy of liver tumors: lessons learned from the registry of the German Society for Interventional Radiology and Minimally Invasive Therapy (DeGIR) 2018-2022. [2023]

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

Percutaneous Liver Tumour Ablation: Image Guidance, Endpoint Assessment, and Quality Control. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Percutaneous ablation of obscure hypovascular liver tumours in challenging locations using arterial CT-portography guidance. [2021]

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

Percutaneous Image-Guided Cryoablation of Hepatic Tumors: Single-Center Experience With Intermediate to Long-Term Outcomes. [2018]

7. Turkey pubmed.ncbi.nlm.nih.gov

Overcoming the heat-sink phenomenon: successful radiofrequency thermal ablation of liver tumors in contact with blood vessels. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Hepato-pericardial fistula following radiofrequency ablation (RFA) for liver metastasis: a case report and review of the literature. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Complications from percutaneous microwave ablation of liver tumours: a pictorial review. [2020]

10. Turkey pubmed.ncbi.nlm.nih.gov

Vascular complications related to image-guided percutaneous thermal ablation of hepatic tumors [2023]

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

Clinical experience with cone-beam CT navigation for tumor ablation. [2019]

12. China pubmed.ncbi.nlm.nih.gov

A national dose analysis of guided tumor destruction: influence of sex, age, localization and destruction technique used. [2022]

13. Romania pubmed.ncbi.nlm.nih.gov

Computed tomography-guided radiofrequency ablation of hepatocellular carcinoma: treatment efficacy and complications. [2016]

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

Image-guided radiofrequency ablation of a pancreatic tumor with a new triple spiral-shaped electrode. [2019]

15. China pubmed.ncbi.nlm.nih.gov

[Clinical value of CT guided radiofrequency ablation in treatment of post-operational resectable liver metastatic tumor from colorectal carcinoma]. [2008]