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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01163526
• Other study ID #: HEP0031
• Secondary ID: SU-07092010-6491
• Status: Terminated
• Phase: N/A
• First received: July 14, 2010
• Last updated: January 26, 2017
• Start date: September 2010
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• CT perfusion

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	GE Healthcare, Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predict RECIST response to treatment		at 3 months from CT perfusion parameters before and after treatment
Secondary	Characterize CT perfusion longitudinally in both responders and nonresponders		1 yr
Secondary	Predict disease progression		1 yr