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Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies


N/A
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors, Brain (Nervous System) Cancers, Colon/Rectal Cancer, Colon Cancer, Hepatobiliary Cancers, Hepatocellular Carcinoma (Hepatoma), Liver

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Trial Information

Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies


Inclusion Criteria:

3.1.1 Patients with suspected or biopsy-proven liver masses including
unresectable hepatocellular carcinoma (HCC), unresectable colon cancer metastases to the
liver, and metastatic neuroendocrine tumors to the liver will be eligible for enrollment.

3.1.2 Patients who have undergone prior chemotherapy more than one year prior to the
study are eligible for enrollment.

3.1.4 Patients must be 18 years or older. Patients must not be pregnant and, if of
child-bearing age, must take precautions not to become pregnant.

3.1.5 No life expectancy restrictions.

3.1.6 ECOG and Karnofsky Performance Status will not be employed.

3.1.7 Patients with renal failure are ineligible for this study (Glomerular filtration
rate (GFR) must be > 60)

3.1.8 Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:3.2.1 Patients who have undergone prior chemoembolization of
hepatocellular carcinoma (HCC) are ineligible for enrollment. Patients who have undergone
chemotherapy within one year prior to the study are also ineligible for enrollment.

3.2.2 No restrictions regarding use of other investigational agents.

3.2.3 Patients with severe contrast allergy are ineligible.

3.2.4 Patients who are pregnant or are trying to become pregnant are excluded from this
study.

3.2.5 Patients who are cancer survivors or Human Immunodeficiency Virus (HIV)-positive
will not be excluded.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Predict RECIST response to treatment

Outcome Time Frame:

at 3 months from CT perfusion parameters before and after treatment

Safety Issue:

No

Principal Investigator

Aya Kamaya

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

HEP0031

NCT ID:

NCT01163526

Start Date:

September 2010

Completion Date:

December 2013

Related Keywords:

  • Neuroendocrine Tumors
  • Brain (Nervous System) Cancers
  • Colon/Rectal Cancer
  • Colon Cancer
  • Hepatobiliary Cancers
  • Hepatocellular Carcinoma (Hepatoma)
  • Liver
  • Carcinoma
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Carcinoma, Hepatocellular
  • Neuroendocrine Tumors

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317