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Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome


Inclusion Criteria:



- Patients with diagnosed with secondary hepatic malignancy;

- Patients with confined liver disease or stable limited extrahepatic disease;

- Lesions of 5cm or less in maximum diameter;

- Patients who are not surgical candidates or refuse to undergo surgery and choose any
percutaneous ablation as an alternative treatment option.

- INR<1.5 *for patients on Coumadin general clinical guidelines for IR ablation will be
followed.

- Platelet count > or = to 50,000

Exclusion Criteria:

- Patients < 18

- Less than 5 mm distance of the tumor margin from a major vessel >7mm in diameter)

- Less than 5 mm distance to a structure (GI or biliary tract), that cannot be
protected from

- the ablation injury with technical modifications such as hydro or air dissection.

- INR > 1.5 that cannot be corrected with fresh frozen Plasma *for patients on Coumadin
general clinical guidelines for IR ablation will be followed.

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

- Patient with more than 3 tumors treated with any percutaneous ablation

- Patients with more than 5 sites of extrahepatic disease (including nodes and
pulmonary nodules)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumor response

Outcome Description:

will be measured according to EASL and RECIST. In the case of differences between these criteria, the EASL criteria will be used for clinical judgment and decisions.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Constantinos Sofocleous, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-122

NCT ID:

NCT01494324

Start Date:

October 2009

Completion Date:

October 2013

Related Keywords:

  • Liver Cancer
  • Liver
  • Thermal Ablation
  • Dynamic CT
  • 09-122
  • Liver Neoplasms
  • Neoplasm Metastasis

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021