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

Primary Purpose

Colorectal Cancer Liver Metastases

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[18-F]- FDG - PET

Thermal ablation (TA)

PET/CT Scan

About this trial

This is an interventional diagnostic trial for Colorectal Cancer Liver Metastases focused on measuring Optimizing Thermal Ablation, Rapid Tissue Analysis, Metabolic Imaging Biomarker Validation, Predictive Genetic Signatures, 19-332

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%20tumors.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

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Colon Cancer Liver Metastases

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04143516

First Posted

October 25, 2019

Last Updated

August 16, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04143516

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2019 (Actual)

Primary Completion Date

October 2026 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer Liver Metastases

Keywords

Optimizing Thermal Ablation, Rapid Tissue Analysis, Metabolic Imaging Biomarker Validation, Predictive Genetic Signatures, 19-332

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

This is a single institution prospective study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with Colon Cancer Liver Metastases

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

[18-F]- FDG - PET

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Thermal ablation (TA)

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

PET/CT Scan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tumor response

Description

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.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%20tumors.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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Constantinos Sofocleous, MD, PhD

Phone

212-639-3379

sofoclec@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Efsevia Vakiani, MD

Phone

646-888-3060

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Constantinos Sofocleous, MD, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Constantinos Sofocleous, MD

Phone

212-639-3379

First Name & Middle Initial & Last Name & Degree

Efsevia Vakiani, MD

Phone

646-888-3060

First Name & Middle Initial & Last Name & Degree

Constantinos Sofocleous, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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

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