Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT00132704
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2005-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Doctors will take some tissue from the tissue removed during surgery in order to study how the blood vessels of the tumor respond to radiation therapy. The tissue obtained will be used to determine how these tumor blood vessels respond to radiation therapy delivered to the tumor, after it has been removed. This radiation is delivered in the research lab. This research is being conducted in order to develop new methods to treat tumors by radiation therapy. No additional surgery will be performed to obtain these samples, and only materials that remain after all diagnostic testing has been completed will be used.
Detailed Description:
The goal of this study is to determine if concepts established in mouse models of the tumor microvascular response to ionizing radiation (IR) therapy are applicable to human tumors in order to begin to establish that the engagement of the endothelial response is a valid target for IR in human tumors. A portion of tumor will be isolated from individuals who have signed informed consent for this protocol and are undergoing surgery on the Neurosurgery, Colorectal, and Gynecology, Head and Neck, Urology, and Hepatobiliary Services at Memorial Sloan-Kettering Cancer Center. Tumor tissue will be obtained from the surgical sample in pathology after adequate specimens have been obtained for diagnostic purposes. Tumor tissue will be irradiated ex vivo and the microvascular endothelial response will be determined. From specimens of adequate size, a pure tumor endothelial cell population will be isolated and the response to IR will be determined.
Primary Outcomes:
* To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.
Secondary Outcomes:
* To determine if tumor endothelium isolated to near homogeneity demonstrates dose parameters similar to those used in single dose radiotherapy of brain tumors.
* To determine if the microvascular endothelium of tumors of different types behaves in a similar fashion in its response to IR.
Primary Outcomes:
* To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.
Secondary Outcomes:
* To determine if tumor endothelium isolated to near homogeneity demonstrates dose parameters similar to those used in single dose radiotherapy of brain tumors.
* To determine if the microvascular endothelium of tumors of different types behaves in a similar fashion in its response to IR.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: