Overview

This trial is active, not recruiting.

Conditions neuroendocrine tumors, brain (nervous system) cancers, colon/rectal cancer, colon cancer, hepatobiliary cancers, hepatocellular carcinoma (hepatoma), liver
Treatment ct perfusion
Sponsor Stanford University
Collaborator Siemens Corporation, Corporate Technology
Start date September 2010
End date July 2016
Trial size 13 participants
Trial identifier NCT01163526, HEP0031, SU-07092010-6491

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
15 patients with neuroendocrine metastases
ct perfusion
15 patients with colon cancer metastases
ct perfusion
15 patients with HCC treated with cyberknife radiation and chemotherapy
ct perfusion
15 patients with HCC treated with Sirsphere embolization and chemotherapy
ct perfusion

Primary Outcomes

Measure
Predict RECIST response to treatment
time frame: at 3 months from CT perfusion parameters before and after treatment

Secondary Outcomes

Measure
Characterize CT perfusion longitudinally in both responders and nonresponders
time frame: 1 yr
Predict disease progression
time frame: 1 yr

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
Principal investigator Aya Kamaya
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stanford University.