Tissue Analysis After Thermal Ablation for Colon Cancer Liver Metastases Leading to Immediate Retreatment

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04143516

Collaborator

(none)

100

Enrollment

Location

Arm

59.2

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will see whether collecting and analyzing needle biopsy samples from colon cancer liver metastases (CLM) after a thermal 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Liver Metastases	Diagnostic Test: [18-F]- FDG - PET Procedure: Thermal ablation (TA) Diagnostic Test: PET/CT Scan	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a single institution prospective study.This is a single institution prospective study.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 25, 2019

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with Colon Cancer Liver Metastases The standard of care thermal 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.	Diagnostic Test: [18-F]- FDG - PET Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion Procedure: Thermal 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 thermal ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of thermal ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.

Arm

Intervention/Treatment

Experimental: Patients with Colon Cancer Liver Metastases

The standard of care thermal 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.

Diagnostic Test: [18-F]- FDG - PET

Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion

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

Outcome Measures

Primary Outcome Measures

Tumor response [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of colorectal cancer liver metastases (CLM)
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***
Any patient with CLM treated with Microwave ablation (as per clinical IR Guidelines)*
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
Institutional IR guidelines:

https://one.mskcc.org/sites/pub/radiology/lptestapp/Split%20Dose%20PET%20Ablation%20Liver%2 0tumors.pdf

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