- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163526
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
neuroendocrine metastases
15 patients with neuroendocrine metastases
|
|
colon cancer metastases
15 patients with colon cancer metastases
|
|
HCC treated with cyberknife radiation and chemotherapy
15 patients with HCC treated with cyberknife radiation and chemotherapy
|
|
HCC treated with Sirsphere embolization and chemotherapy
15 patients with HCC treated with Sirsphere embolization and chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Predict RECIST response to treatment
Time Frame: at 3 months from CT perfusion parameters before and after treatment
|
at 3 months from CT perfusion parameters before and after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterize CT perfusion longitudinally in both responders and nonresponders
Time Frame: 1 yr
|
1 yr
|
Predict disease progression
Time Frame: 1 yr
|
1 yr
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aya Kamaya, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEP0031
- SU-07092010-6491 (Other Identifier: Stanford University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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