Ms. Masada Disenhouse
NYS Center for Advanced Technology in Ultrafast Photonics
One Bernard Baruch Way
Box J-1028
New York, NY 10010
Phone: 646 312 2217
Fax: 646 312 2219
E-mail: Masada_Disenhouse@baruch.cuny.edu
Number of Human Subjects projects reported: 3
| CUNY-98-H0104-C | "Breast Cancer Program: Optical Mammography (Formerly CUNY-98-H9938-C)" |
| CUNY-99-H0103-C | "Skin Subsurface Imaging Using Spectral and Polarization Imaging (Formerly CUNY-99-H9939-C)" |
| CUNY-99-MTC/YALE | "Hormone Levels Probed by Fluorescence Spectroscopy of the Female Genitalia" |
"Breast Cancer Program: Optical Mammography (Formerly CUNY-98-H9938-C)"
Principal Investigator: Dr. Robert R. Alfano, City University of New York
Project started in: 1998
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: City University of New York
Most recent approval: 01/17/01
IRB approval number: H-0104-C
Explanation of IRB approval:
IRB approval was not renewed since human subject participation in this project in fiscal year 2002 was not expected
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 2002
Type(s) of Human Subjects Involvement:
The objective of the project is to develop a noninvasive non-ionizing breast cancer screening modality with diagnostic ability using near-infrared light.
The methodology of the study is based on the use of picosecond (ps) laser pulses as the probing source and an ultrafast shutter to select the earlier arrival photons with the minimum distortion. When photons migrate through a random media, such as the human breast, there are three main contributions to the transmitted light: diffusive (incoherent, scattered), ballistic (coherent, unscattered, first arriving photons, shortest time-to-flight), and snake (nearly unscattered, photons arriving during the first 10-ps). The diffusive portion of the signal travels over a much longer distance than the ballistic and snake parts that take the shorter paths through the medium within a small forward cone. The diffusive part introduces noise mixing with the undistorted signal and scrambles the information to be imaged or mapped. The ballistic and snake photons carry the least distorted image and can be measured using time-gated techniques. With the advancement of ultrashort laser pulses, a 100 micron spatial resolution of the optical image in modeled systems and human breast tissues in vitro has been achieved. Based on time-resolved imaging that restricts detection to the earliest arriving photons, 1 mm spatial resolution of the transient image of the human breast in vivo can be obtained using a ps time gate.
The procedures involving human subjects are as follows:
A human subject (woman) in this study will be asked (1) to take one section of optical imaging through her right breast at CCNY, (2) to take one conventional x-ray mammography at Memorial Sloan-Kettering Cancer Center (MSKCC), and (3) to take another section of optical imaging at CCNY after x-ray mammography. There is no intention to diagnose disease from this study. If there are any findings from the mammography, physicians at MSKCC will be responsible for informing the subject. The subject will not pay anything, except her own transportation. After the completion of the measurements, the subject will receive a $100 check in mail to compensate for her time and any expenses.
For the optical imaging study, the subject will lie on her chest on a mammography bed. One of subject's breasts will hang down through an opening in the bed and will be placed between a pair of plastic plates. The plates may be moved with respect to each other and thus to compress the breast to provide uniform thickness. There may be minor discomfort due to the low pressure compression (~ 25 lbs or 0.25 newtons/cm2) from the plates. Under any conditions, the subject can ask to stop the compression procedure. Laser light will illuminate the compressed breast through one of the plates, and the transmitted light will be collected through the second plate. Several exposures will be taken from different directions. Each exposure time should be less than ten minutes. The total experimental time will be under two hours for one session. The transmitted light will be recorded by a time gated charge couple device (CCD) camera that can store and digitize image information. The subject can withdraw at any time without penalties.
The identity of the subject as a participant in this research will remain confidential. Any publication or presentation of the results of this study will not identify the subject except in general terms such as age or race group. The records in this study will be kept confidential to the extent permitted by law. If the subject will have any questions or if any problems arise as a result of her participation in this research, she should contact the PI of the project.
The participating subject will be supplied with laser safety goggles that she will wear to protect her eyes from laser beams. There are no known risks associated with the low energy near infrared laser pulses other than the direct illumination to unprotected eyes. There will be no benefit to the participating subject directly except the $100 compensation for her time and expenses. Information obtained from her participation will help to obtain more knowledge towards developing a new method of optical screening of breast cancer.
"Skin Subsurface Imaging Using Spectral and Polarization Imaging (Formerly CUNY-99-H9939-C)"
Principal Investigator: Dr. Robert R. Alfano, City University of New York
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: City University of New York
Most recent approval: 02/08/01
IRB approval number: H-0103-C
Explanation of IRB approval:
IRB approval was not renewed since human subject participation in this project in fiscal year 2002 was not expected
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 2002
Type(s) of Human Subjects Involvement:
Objective
The objective of the project to employ non linear optics (second harmonic generation and two photon fluorescence) to develop noninvasive in situ and in vivo tomographic and histologic techniques to construct 3-D layered structure maps of symmetry and content of native fluorophors in human tissue. One may use these images to distinguish regions on a tissue at different states: normal, benign, pre-cancer, and cancerous.
Methodology
Research methodology is based on the sub-micron resolution and structural response from non-linear optical signals (harmonic generation and multi-photon excitation of fluorescence). 3-D images will be obtained by mapping the non linear signal generated from a focused, ultra short pulsed laser system, using depth (z) and lateral (x, y) scanning.
Involvement of human subjects
To date, no measurements have been performed on human subjects. In the future, volunteer subjects will be recruited for participation in this study.
The procedures involving human subjects will be as follows: The subject will sit on a chair and leave one of his fingers, hands, or arms on a platform to be illuminated by a light source. There should be no physical pain at all under any conditions. It may take five exposures with each exposure time less than 5 minutes. The total experimental time should be less than 2 hours and the total exposure time should be less than 30 minutes. During the exposure, if the subject will feel any symptoms of heat or burning, he can ask to stop the experiment immediately. The low energy laser pulses will be directing toward the subject's finger, hand, or arm and the emitted signal light will be recorded by a charge-couple-device (CCD) camera. The subject can withdraw at any time without penalty.
The identity of a participant in this research will remain confidential. Any publication or presentation of the results of this study will not identify the subject in any way without his prior approval. The records in this study will be kept confidential to the extent permitted by law.
If the subject will have any questions or if any problems arise as a result of his participation in this research, he should contact PI of the project. There will be no benefit to the subject directly, besides the knowledge that he will be contributing to a better understanding of imaging of skins.
Risks
To our knowledge, there is no known data to report the safety hazard at the planned excitation energy and power levels. The nonlinear processes will generate low levels of UVA radiation (320 to 400 nm). Subjects may be exposed to this radiation. It is estimated that the maximum UV exposure will be less than 3 mJ/cm2.
"Hormone Levels Probed by Fluorescence Spectroscopy of the Female Genitalia"
Principal Investigator: Dr. Robert R. Alfano, City University of New York
Project started in: 1999
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: City University of New York
Most recent approval: 02/23/01
IRB approval number: H-0109-C
Explanation of IRB approval:
IRB approval was not renewed since a decision was made not to recruit human subjects for this project until contractual issues can be resolved
Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Yale School of Medicine
Most recent approval: 04/03/00
IRB approval number: HIC 9211
Explanation of additional approval:
IRB approval was not renewed since a decision was made not to recruit human subjects for this project until contractual issues can be resolved
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 2002
Type(s) of Human Subjects Involvement:
Objectives:
Investigate the capability of using native fluorescence spectroscopy of the female genitalia for the purpose of monitoring hormone levels.
Methodology:
Perform emission and excitation fluorescence measurements from the vulva in the blue and UVA spectral regions. Fluorescence from the gum and fourchette on the vulva was measured during clinic visits. Fluorescence measurements were performed on the subject using the Mediscience Technology CD-Scan. Basil body temperature and first morning urine were collected to measure levels of estrogen and progesterone in the urine. Spectra were analyzed to determine if the emission intensity or wavelength from collagen and other tissue fluorophores change with the menstrual cycle and dosage of fertility drugs.
Involvement of Human Subjects:
Subjects were accrued from patients and nursing staff at the Department of Reproductive Medicine at Yale University School of Medicine / Yale New Haven Hospital. Informed consent was acquired from each subject prior to performing any measurements. Nurses were instructed in the use of the CD-Scan spectrometer by a physician, prior to initiating measurements. Measurements performed on volunteer nurses were self-performed. Measurements taken from patient volunteers were performed by the nursing staff at the hospital. Measurements are made by placing one end of a fiber optic probe in contact with the vulva using minimum pressure to maintain contact. Subjects were instructed to position the probe at the same location for each series of measurements. Data collection was controlled by the CD-Scan computer and is fully automated. The measurements consist of six scans and take about five minutes to complete. During this time, patients were exposed to approximately 0.7 millijoules/cm^2 of UVA radiation. This compares to the threshold limit value of 2900 millijoules/cm^2 at 320 nm, established by the American Conference of Governmental and Industrial Hygienists (ACGIH).
Patient confidentiality is preserved by having a unique study number assigned to each subject and only identifying scans by this number.