USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-89-113-H01

Project Title:

Heavy Ion Radiosurgery (see LBL-93-4-56 in 1994 database)

Principle Investigator: Dr. Richard P. Levy

Project started in: 1989

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Explanation:

This project is no longer funded because closure of the Bevatron facility has prevented treatment of additional patient-research subjects; these subjects have been transferred.

Information on Use of Human Subjects:

Project involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 2

Protocol/Subproject # 1
Protocol/Subproject Identifier: 94-8-98

IRB Review:
Type of Review: Full Board
Most Recent Approval: April 17, 1995
IRB Approval Number: 95-4-86

Number of Human Subjects in the Last Reporting Period for this Project: 25
(Reporting periods vary.)

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.

(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])

OBJECTIVES

The objective of this study is to continue the investigation and development of stereotactic heavy charged particle Bragg peak radiosurgery of arteriovenous malformations (AVM) and pituitary cancers. It is hoped that review of AVM patient medical records and inquiries into the current health status of these persons will increase understanding of the effectiveness and benefits of AVM radiosurgery therapy.

METHODOLOGY

Medical records are reviewed regarding the 840 subjects who received treatment at LBNL between 1954 and 1982. In a second phase, surviving patients and/or their attending physicians are contacted to receive authorization to review records not under University of California jurisdiction. The researchers then contact the patients or physicians via phone and/or mail regarding current or pre-mortem states of health.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

There is no foreseeable risk to the subjects as the medical information is pre-existing and will require no further medical intervention.

IRB Review:
Type of Review: Full Board
Most Recent Approval: February 17, 1995
IRB Approval Number: 95-2-106

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For therapeutic research.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.

(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])

(see LBL-94-1-59 in 1994 database)

OBJECTIVES

Since the Bevatron's closure in 1992, there has been no arteriovenous malformation (AVM) treatment facility. The objective of this study is to permit LBNL researchers to consult Loma Linda Medical Center in the establishment of a stereotactic proton-treatment facility for AVMs.

METHODOLOGY

No subjects will be treated at LBNL. LBNL researchers will act as consultants to researchers and staff at Loma Linda Medical Center.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

LBNL involvement is limited to consulting on project development, patient selection, and treatment planning. No subjects are exposed to a risk at or through the actions of LBNL researchers as all evaluation and treatment procedures are carried out at the Loma Linda Medical Center under their IRB-approved protocol.