Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
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Purpose
The purpose of this study is to determine whether baseline CT perfusion characteristics (measurements of blood-flow using CT) of hepatic cancers can predict tumor response to treatment and whether perfusion CT after treatment can be used as a biomarker for response to treatment. Treatment may consist of chemotherapy or stereotactic body radiotherapy (SBRT)or embolization therapy.
| Condition | Intervention |
|---|---|
|
Neuroendocrine Tumors Brain (Nervous System) Cancers Colon/Rectal Cancer Colon Cancer Hepatobiliary Cancers Hepatocellular Carcinoma (Hepatoma) Liver |
Procedure: CT perfusion |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies |
- Predict RECIST response to treatment [ Time Frame: at 3 months from CT perfusion parameters before and after treatment ] [ Designated as safety issue: No ]
- Characterize CT perfusion longitudinally in both responders and nonresponders [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
- Predict disease progression [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
neuroendocrine metastases
15 patients with neuroendocrine metastases
|
Procedure: CT perfusion |
|
colon cancer metastases
15 patients with colon cancer metastases
|
Procedure: CT perfusion |
|
HCC treated with cyberknife radiation and chemotherapy
15 patients with HCC treated with cyberknife radiation and chemotherapy
|
Procedure: CT perfusion |
|
HCC treated with Sirsphere embolization and chemotherapy
15 patients with HCC treated with Sirsphere embolization and chemotherapy
|
Procedure: CT perfusion |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Contact: Lindee Burton | (650) 725-4712 | lburton@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Lindee Burton 650-725-4712 lburton@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Aya Kamaya | |
| Sub-Investigator: Juergen Karl Willmann | |
| Sub-Investigator: Samuel So | |
| Sub-Investigator: Dr. John D Louie | |
| Sub-Investigator: Pamela Kunz | |
| Sub-Investigator: Nishita N. Kothary | |
| Sub-Investigator: Albert Koong | |
| Sub-Investigator: Dominik Fleischmann | |
| Sub-Investigator: George Albert Fisher M.D. Ph.D. | |
| Sub-Investigator: Cheryl Cho-Phan | |
| Sub-Investigator: Daniel T Chang | |
| Principal Investigator: | Aya Kamaya | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01163526 History of Changes |
| Other Study ID Numbers: | HEP0031, SU-07092010-6491 |
| Study First Received: | July 14, 2010 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Colonic Neoplasms Rectal Neoplasms Carcinoma, Hepatocellular Neuroendocrine Tumors Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Adenocarcinoma Liver Neoplasms Liver Diseases Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013