Clinical trial NCT01163526: Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
Official title: Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuroendocrine Tumors
Brain (Nervous System) Cancers
Colon/Rectal Cancer
Colon Cancer
Hepatobiliary Cancers
Hepatocellular Carcinoma (Hepatoma)
Liver
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
name: GE Healthcare
First posted: 2010-07-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Predict RECIST response to treatment
timeFrame: at 3 months from CT perfusion parameters before and after treatment
Secondary outcomes:
measure: Characterize CT perfusion longitudinally in both responders and nonresponders
timeFrame: 1 yr
measure: Predict disease progression
timeFrame: 1 yr
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Aya Kamaya
role: PRINCIPAL_INVESTIGATOR
References: