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Clinical Application of Image Guided Liver Surgery


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

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Trial Information

Clinical Application of Image Guided Liver Surgery


Inclusion Criteria:



- Written informed consent must be obtained.

- Patient must be 18 years or older.

- Are male or non-pregnant, non-lactating females.

- Patients enrolled in Phase I must be candidates for surgical liver resection per a
treating surgeon's discretion. Patients enrolled in Phase 2-3 must be candidates for
surgical liver resection of liver mass. Patients enrolled in Phase 4 must be
candidates for surgical ablation, but not candidates for surgical resection

Exclusion Criteria:

- Any condition which, in the judgment of the investigator, might increase the risk to
the subject or decrease the chance of obtaining satisfactory data to achieve the
objectives of the study.

- Mental condition rendering the subject or his/her legal representative unable to
understand informed consent to the nature, scope, and possible consequences of the
study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To reach success in complete ablation of liver cancer tumors as well as no recurrence of the tumor within 6 months.

Outcome Time Frame:

no recurrence of tumor within 6 months

Safety Issue:

No

Principal Investigator

William C Chapman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University Medical School

Authority:

United States: Institutional Review Board

Study ID:

02-0836

NCT ID:

NCT00878215

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Hepatocellular Cancer
  • Image Guided Liver Surgery
  • Liver Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110