USDOE Human Subjects Research Database, Fiscal Year 2004

Sloan-Kettering Institute for Cancer Research

Public Information Contact:

Mr. F. Edward Herran
Sponsored Projects, MSKCC Box 40
1275 York Avenue
New York, NY 10021

Phone: 646-227-3273
Fax: 212-577-0760
E-mail: herranf@mskcc.org

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Sloan-Kettering Institute for Cancer Research
The approving IRB operates under an OHRP assurance.
OHRP assurance number: FWA00004998

Human Subject Projects:

Number of Human Subjects projects reported: 2

SKI-86-ER60407 "Improving Cancer Treatment with Cyclotron Produced Radionuclides"
SKI-95-ER62039 "Pharmacokinetics of Genetically Engineered Antibody Forms Using Positron Emission Tomography"

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Project Identifier: SKI-86-ER60407

Project Title:
"Improving Cancer Treatment with Cyclotron Produced Radionuclides"

Principal Investigator: Dr. Steven M. Larson, Sloan-Kettering Institute

Project started in: 1986

Project Funding Information:

This project received funding during fiscal year 2004.
This project did not use human subjects in fiscal year 2004.
Explanation: Predominant effort is focused on pre-clinical studies.

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)
$0.00 (Est.) for: Fiscal Year 2004
Pilot and demonstration projects only, designed to obtain basic physiologic information.

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: none

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Sloan-Kettering Institute for Cancer Research
Most recent approval: 04/10/01
Explanation of IRB approval:
Protocol closed 4/9/02. No human subjects used in FY2004.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 2004

Type(s) of Human Subjects Involvement:

Abstract:

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

No human subjects used in FY2004. Predominant effort was focused on pre-clinical studies.

Go to list of projects at Sloan-Kettering Institute for Cancer Research

Project Identifier: SKI-95-ER62039

Project Title:
"Pharmacokinetics of Genetically Engineered Antibody Forms Using Positron Emission Tomography"

Principal Investigator: Dr. Steven M. Larson, Sloan-Kettering Institute for Cancer Research

Project started in: 1995
This project ended in fiscal year 2004.

Project Funding Information:

This project received funding during fiscal year 2004.
This project did not use human subjects in fiscal year 2004.
Explanation: Development of specific labeled reagents and also on-going physics support work was required. No work involving human subjects was performed, and this project was terminated as of May 31, 2004.

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)
$0.00 (Est.) for: Fiscal Year 2004
Physics of imaging detection, radiochemistry development, and pre-clinical testing in animals formed the bulk of the work in this period; clinical protocols are pending.

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: none

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Sloan-Kettering Institute for Cancer Research
Most recent approval: 02/22/00
Explanation of IRB approval:
As reported last year, the protocol was CLOSED on 2/13/01.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects: Fiscal Year 2004

Type(s) of Human Subjects Involvement:

Other types of human subjects involvement. Explanation:
No human subjects used in FY2004.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

No human subjects activity in FY2004.

Go to list of projects at Sloan-Kettering Institute for Cancer Research