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

Liver Metastases Clinical Trial

Official title:

Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143516
• Other study ID #: 19-332
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2019
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Constantinos Sofocleous, MD, PhD
• Phone: 212-639-3379
• Email: sofoclec[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of liver metastases from various primary tumors

• Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)

• Lesions of =3 cm in maximum diameter

• At least one FDG-avid lesion to be treated***

• INR < 1.5*

• Platelet count = 50,000

Exclusion Criteria:

• Age < 18

• Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection

• INR > 1.5 that cannot be corrected with fresh frozen plasma **

• Platelet count of <50,000 that cannot be corrected with transfusion

• More than 3 tumors in the liver

• More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)

• Presence of any peritoneal Carcinomatosis

• For patients on Coumadin, general clinical guidelines for IR ablation will be followed.

• For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• [18-F]- FDG - PET
Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion

Procedure:
• Tumor ablation (TA)
Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed.

Diagnostic Test:
• PET/CT Scan
Eligible patients will undergo PET/CT -guided tumor ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of tumor ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response	will be measured according to RECIST and PERCIST 1.0. The first CT and PET scan taken after ablation will be considered the new baseline for subsequent comparisons and measurements.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center