Dr. Vincent
Tomaselli
Research Foundation of City University of New York
30 West Broadway
New York, NY 10003
Phone: 212 417 8320
Fax: 212 417 6448
E-mail: vptrf@cunyvm.cuny.edu
Number of Human Subjects projects reported: 4
Project Identifier:
CUNY-98-H-9735
Project Title:
"Near Infrared Spectroscopy (NIRS) in Patients with Obstructive Sleep Apnea Syndromes"
Principal Investigator: Dr. Arthur Spielman, City University of New York
Project started in: 1998
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 02/05/98
IRB approval number: H-9735
Explanation of IRB approval:
All the experiments on human subjects were conducted between February 5, 1998 and February 4, 1999. It is intended to obtain a new IRB approval in December 1999.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 11
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
One of the series sleep disorder diseases is obstructive sleep apnea syndrome (OSAS). OSAS is described as a potentially lethal disease because it leads to hypoxia and hypoxemia. Since the brain is very sensitive to hypoxia, the recurrent decrease of the arterial oxygen saturation in sleep apnea could cause the patient to not get enough rest, to induce brain injury, and even to cause death during the sleep apnea status.
Conventional polysomnography detects sleep apnea in correlation to the various sleep stages and the finger pulse oximetry signal is used to determine arterial oxygen saturation, but does not provide information on brain oxygenation, especially in subjects with preexisting anatomical functional vascular pathology.
The methodology of the study of OSAS patient subjects is to investigate the brain blood dynamic changes that accompany recurrent episodes of obstructive hypopnea during sleep. Two diode lasers were used at 830 nm and 780 nm. These wavelengths were selected on each side of the isobastic point of the oxy-hemoglobin and deoxy-hemoglobin absorption spectra around ~800 nm. The beam was modulated at different low frequencies, 367 Hz and 600 Hz, respectively. The light propagates through a 1.0-mm optical fiber to the sample surface of the subject about 0.25 mw (0.1 mw for 780 nm and 0.15 mw for 830 nm) at the output point. The output power of the fiber is set below 0.32 mw for each wavelength at a level safe for human subjects. A 5-mm diameter liquid optical waveguide will be used to collect the optical signal at a distance 3-cm away from the pump fiber. The collected optical signal is passed through a wide band filter center wavelength 800 nm to remove the environment light noise, and is then transformed to an electrical signal by a single photo multiplier tube. Two PC-board lock-in amplifiers are used for detection. The two wavelengths optical signals were detected at the chopped frequencies read out from the two lock-in amplifier outputs and recorded in a computer data file for post data processing. The optical fiber probes were placed 3 cm apart and embedded in an elastic headband with a perpendicular orientation to the surface of the forehead. Symmetrically positioned across the midline, the input probe was to the left and the detector probe to the right. Both probes were approximately equidistant from the eyebrows and hairline. Bipolar EEG signals and the NIRS signals were simultaneously recorded by connecting to a polygraph recorder and a PC computer based digital recorder. For the daytime nap experiment, the arterial blood oxygenation (SaO2) status was obtained from a finger of the subject by a finger pulse oximeter. The breath property was obtained from the nose tidal air by an end tidal CO2 monitor. The SaO2 signal, end tidal CO2 signal and the NIRS signals were simultaneously recorded by connecting to a polygraph recorder and a PC computer based digital recorder.
Procedure: The napping protocol was made from 2 to 5 p.m. Following preliminary calibrations and 3 minutes of waking recording with eyes alternatively opened and closed, the room lights were turned off, and the subject was requested to stop breathing by the order of the operator to produce an artificial apnea for comparison with sleep apnea. After three trails of the breathing holding test, the door of the sound attenuated room was closed and the subject was told to go to sleep. The nighttime sleep began around 11 p.m., the typical sleep time of the subject. An additional air mask was hooked up on the subjects face and connected to a continuous positive airway pressure (CPAP) treatment equipment to help improve the breathing quality of the subject during the night sleep. The beginning procedure is the same as the nap experiment. Following preliminary calibrations and 3 minutes of waking recording with eyes alternatively opened and closed, the room lights were turned off, and the subject was requested to stop breathing by the order of the operator to produce an artificial apnea for comparison with sleep apnea. After three trails of the breathing holding test, the door of the sound attenuated room closed and the subject was told to go to sleep. Nasal continuous positive airway pressure (NCPAP) was set at 3 cm of H2O at the start of the nocturnal polysomnogram. Shortly after falling asleep CPAP was increased to 6 cm of H2O and this resolved the mixed obstructive apneas.
The risks for human subjects associated with this study are minimal:
1. On the basis of studies that have been done there are no known risks associated with the low power near-infrared laser light used in this study. According to the standards established by the American National Standards Institute (Safe Use for Lasers, 1993) the level of light and time of exposure used in this study falls within the category that is considered to be incapable of producing damaging radiation levels.
2. Abrasions or pressure at the site of electrodes or light source or detectors may occur. If an abrasion occurs the technician on duty will have an ointment available that the human subject may use if he wishes. If the subject feels pressure from a sensor or light source the technician will make adjustments to alleviate the pressure.
The identity of the participating person(s) will remain confidential. Any publication or presentation of the results of this study will not identify the subject(s) in any way. The records of the study will be kept confidential to the extent permitted by law.
Project Identifier:
CUNY-98-H9938-C
Project Title:
"Breast Cancer Program: Optical Mammography"
Principal Investigator: Dr. Robert R. Alfano, City University of New York
Project started in: 1998
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
Most recent IRB approval: 10/29/99
IRB approval number: H9938-C
Explanation of IRB approval:
Date of most recent renewal
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 1999 (10/1/98-9/30/99)
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 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 which 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 which 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:
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 (MSKC), 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 MSKC will be responsible for informing the woman. The woman will not pay anything, except her own transportation. After the completion of the measurements, the woman will receive a $100 check in mail to compensate for her time and any expenses.
For the optical imaging study, the woman will lay on a mammography bed. One of woman's breasts will be situated between a pair of plastic plates to be illuminated by a laser source. There should be minor discomfort due to the low pressure compression (~ 25 lbs or 0.25 newtons/cm2) from the plates. Under any conditions, the woman can ask to stop the compression procedure. 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 section. Laser pulses will be directing toward the woman's breast and the transmitted light will be recorded by a time gated CCD camera. A CCD camera stands for a charge-couple-device which can store and digitize image information. The woman can withdraw at any time without penalties.
The identity of the woman as a participant in this research will remain confidential. Without her prior approval, any publication or presentation of the result of this study will not identify her 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 women 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 women will be supplied with laser safety goggles which 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 woman directly except the $100 compensation to my time and expense. Information obtained from her participation will help toward the knowledge to a better understanding of optical screening of breast cancer.
Project Identifier:
CUNY-99-H9939-C
Project Title:
"Subsurface Imaging for Detection of Skin Lesions, such as Melanoma, Using Polarization Imaging"
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
Most recent IRB approval: 10/29/99
IRB approval number: H9939-C
Explanation of IRB approval:
Date of most recent renewal
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 1999 (10/1/98-9/30/99)
Type(s) of Human Subjects Involvement:
The objective of the project is to detect skin cancers at an early stage in a noninvasive detection using spectral polarization techniques.
The skin has three layers: the epidermis, dermis, and subcutis. Skin cancers are divided into two general types - melanoma and nonmelanoma skin cancers. Melanoma is a cancer that begins in the melanocytes, the cells that produce the skin coloring or pigment known as melanin. Because most melanoma cells still produce melanin, melanoma tumors are often brown or black. Non-melanoma skin cancers are the most common cancers of the skin. They are called non-melanoma because this group of cancers includes all skin cancers except one - malignant melanoma.
Tissues scatter, absorb and emit light with their own character fingerprints. Based on the spectral and polarization properties of light scattered, absorbed and emitted from normal and cancerous skin tissues, we have developed a near infrared spectral polarization imaging technique, and build a broadband spectral polarization imaging instrument.
The spectral and polarization difference imaging technique can enhance the visibility of an object (cancer) at some depth (few millimeters) beneath the upper layer of the skin. This technique is a promising one to evaluate subsurface structures and defects in scattering media such as skin tissue in a non-invasive way. The set up consists of a laser or white light source for illuminating samples, a set of spectral filters and polarizers for changing the imaging conditions, and a CCD system for recording and analyzing images. Since this method removes the diffusion effect and remains the ballistic component contribution, the image quality is significantly enhanced over a few cm underneath the upper skin layer.
A compact, hand held prototype spectral polarization imaging unit has been constructed. This unit employs three light sources (red, green, and blue) and a CCD camera with radio frequency connection to a remote computer to generate color images of the skin. Current unit excites at different angles to give different views of the same target area. This unit will be available for preliminary testing at Memorial Sloan Kettering Cancer Center (MSKCC).
The procedures involving human subjects are as follows:
The human subject will sit on a chair and leave one of his fingers, hands, or arms on a platform to be illuminated by a laser 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 CCD camera. A CCD camera stands for a charge-couple-device which can store and digitize image information. The subject can withdraw at any time he or she wish without penalty.
The identity of a participant in this research will remain confidential. Any publication or presentation of the result 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 are no known risks associated with the low energy laser sources.
There will be no benefit to to the subject directly, besides the knowledge that he will be contributing to a better understanding of imaging of skins.
Project Identifier:
CUNY-99-MTC/YALE
Project Title:
"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:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Most recent IRB approval: 01/20/99
IRB approval number: HIC#9211
Explanation of IRB approval:
CCNY IRB has determined that this project is exempt from the regulations governing human subjects. CCNY personnel have no interaction or involvement with any identifiable subjects in this project. Yale Hospital's MPA number is M-1452.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 5
Reporting period for number of human subjects:
Fiscal Year 1999 (10/1/98-9/30/99)
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. Data will be collected from patients at various times during their menstrual cycle and the spectra will be analyzed to determine if the emission intensity or wavelength from collagen and other tissue fluorophores change during the patient's cycle.
Involvement of Human Subjects:
Subjects are recruited from patients at the Yale New Haven Hospital In Vitro Fertilization Clinic by hospital staff. Informed consent is acquired from each patient prior to performing any measurements. Data is collected from patient volunteers during a scheduled examination. Fluorescence measurements are performed by the examining physican using the Mediscience Technology CD-Scan. Measurements are made by placing one end of a fiber optic probe in contact with the vulva using the minimum pressure to maintain contact. Data collection is 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 are 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 patient and only identifying patient scans by this number.