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

Stanford University

Status: Terminated

Conditions: Brain (Nervous System) Cancers; Colon/Rectal Cancer; Hepatobiliary Cancers; Hepatocellular Carcinoma (Hepatoma); Colon Cancer; Neuroendocrine Tumors; Liver

Treatments: Procedure: CT perfusion

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01163526

SU-07092010-6491 (Other Identifier)

HEP0031

Details and patient eligibility

About

A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

13 participants in 4 patient groups

neuroendocrine metastases

Description:

15 patients with neuroendocrine metastases

Treatment:

Procedure: CT perfusion

colon cancer metastases

Description:

15 patients with colon cancer metastases

Treatment:

Procedure: CT perfusion

HCC treated with cyberknife radiation and chemotherapy

Description:

15 patients with HCC treated with cyberknife radiation and chemotherapy

Treatment:

Procedure: CT perfusion

HCC treated with Sirsphere embolization and chemotherapy

Description:

15 patients with HCC treated with Sirsphere embolization and chemotherapy

Treatment:

Procedure: CT perfusion