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Procedure

Thermal Ablation for Colon Cancer Liver Metastases

Phase 2 & 3

Recruiting

Led By Constantinos Sofocleous, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lesions of ≤3 cm in maximum diameter

Diagnosis of colorectal cancer liver metastases (CLM)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether taking needle biopsies from colon cancer liver metastases after a thermal ablation procedure can help identify which cancer cells are still alive. The results of these biopsies could help determine the next treatment, but the biopsies could cause side effects.

Who is the study for?

This trial is for people with colorectal cancer that has spread to the liver. They should have at least one lesion visible on a PET scan, a sufficient platelet count, and stable liver or limited extrahepatic disease. The study excludes those who don't meet these criteria.Check my eligibility

What is being tested?

The study tests if analyzing tissue samples after tumor ablation can detect living cancer cells in the liver. This could guide further treatment decisions. Participants will undergo tumor ablation followed by PET/CT scans.See study design

What are the potential side effects?

Possible side effects include complications from needle biopsies such as pain, bleeding, infection, and potential damage to surrounding tissues or organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer lesion is 3 cm or smaller.

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I have been diagnosed with liver metastases from colorectal cancer.

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I have had microwave ablation treatment for my liver metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor response

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with Liver MetastasesExperimental Treatment3 Interventions

The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT Scan

2013

Completed Phase 2

~1370

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,655 Total Patients Enrolled

Constantinos Sofocleous, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

Thermal ablation (TA) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04143516 — Phase 2 & 3

Liver Metastases Research Study Groups: Patients with Liver Metastases

Liver Metastases Clinical Trial 2023: Thermal ablation (TA) Highlights & Side Effects. Trial Name: NCT04143516 — Phase 2 & 3

Thermal ablation (TA) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04143516 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might there still be room for me in this experiment?

"That is correct. At this time, the clinical trial detailed on clinicaltrials.gov is recruiting patients. The first posting was on October 25th, 2019 with the most recent edit being on February 16th, 2022. The study will have 100 patients at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

2019. "Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04143516.