It's been 20 years and more now, but Robert Alfano, PhD, clearly remembers when the light went on a light of the fluorescence sort and the person very close to him who served to put this particular type of illuminating technology onto his entrepreneurial radar.
It was the early 1980s, he says, and his daughter went to her dentist and "was undergoing a lot of X-rays. And [afterwards] she said, 'There must be a better way to do this.'
"And that led me to think about using light for dental care," Alfano told Diagnostics & Imaging Week, leading then to other possibilities only now being developed.
Alfano, currently distinguished professor of science and engineering at the City University of New York (CUNY), said that after the initial perception, he and his daughter kept pursuing the idea. He began looking at the fluorescence of teeth in checking for cavities (at the office of his own dentist), and she, while in the pursuit of a university fellowship, began experiments that used a basic laser on rat tissues, ex vivo.
Alfano says they found that "the spectra was different," Alfano, and they then "checked out what we did it was real."
The next opportunity to take this perception further had to wait for the development of more sophisticated laser systems, along with Alfano's work in material science. Then came contacts with Mediscience (Cherry Hill, New Jersey).
Mediscience, he says, "wanted to use this [system of light] in a device."
The result, Alfano explains, was the use of a visible laser in a device to create a clear differentiation in the molecules making up normal tissues and those making up cancerous ones in the human body.
The product of Alfano's original perception and Mediscience's developmental work are systems for aiding in the detection of breast cancer and also cervical cancer.
The company's Cancer Detection (CD) Map is under development for adjunctive use in acquiring fluorescence images from surgical breast specimens, ex vivo, following lumpectomies and surgical procedures.
Mediscience is currently developing "the second iteration" of the CD-Map and is hoping to launch the first human trial for its use in nine to 12 months, Michael Engelhart, president and chief operating officer of Mediscience, told D&IW.
The instrument will be used "to define the margins of tumors at the point-of-care," with that information thus enabling the physician to have greater ability to achieve those margins "in real time during cancer surgery without the use of extrinsic dyes, drugs or other invasive agents."
Engelhart says that the company's own studies with the technology in ex vivo tissue specimens have demonstrated that acquired fluorescence images "can define regions of cancer, as well as identify other structures such as veins and glands inside tissue." He adds: "We believe the CD-Map [may] greatly enhance patient outcomes at point of care through the delivery of clear margins confirmed through a pathology report."
Alfano calls the underlying approach of Mediscience's developmental efforts "obvious" but that no one had attempted to develop this strategy in the way he and the company have approached the problem.
The collagen that holds tissues together, he describes as "rich and robust with molecules, but nobody thought about exciting these."
He further explains: "It's obvious when something goes bad with [tissues] the molecules change," and the changes, because consistent, can be tracked with fluorescent light. And by analyzing the layers of tissues below the surface of skin, he says, "you get these maps, you see the cancer breaking through the membranes."
The CD-Map system can procure this imaging "map" in less than one second. And it features a zoom capability enabling image acquisition over an area that can vary from sub-centimeter to several centimeters with a resolution better than 100 mm, according to the company.
Specifically, Mediscience says, "the CD-Map employs UV/visible fluorescence imaging to gain image emission from native fluorophors in tissue. A tunable light source and movable filters permit the acquisition of images at multiple combinations of emission and excitation wavelengths. Intensity ratio maps are computer generated from the fluorescence images and either the intensity images or pseudo-color ratio images are displayed."
Alfano says that Mediscience's work to extend his original perception and research work may well represent "the next major advance in [diagnostic] medicine by enabling non-invasive biopsy approaches," and he compares it to the magical scanning devices so often employed by the "Star Trek" character Dr. Spock.
As a caveat, however, he notes that the current technology will have to be carried considerably further or in this case, deeper. Use of the fluorescene mapping system only works for imaging tissues a millimeter under the skin.
But with further advances, he says that the system could go a long way to avoid removal of tissue while obtaining "instant information about what's going on in the tissues, fast results that will play an important role to take appropriate action."
While Mediscience moves forward in development of the CD-MAP system, its Medi-Photonics Development (New York) division is pushing regulatory efforts for its CD-Radiometer system, which uses spectroscopy to analyze the changes, such as scattering and absorption, in the fluorescence properties of tissues.
Medi-Photonics last week reported that it is seeking a pre-investigational device exemption meeting with the FDA concerning the CD-Radiometer, with a focus on diagnosing cancer of the cervix and other abnormalities.
Engelhart said that the purpose of the sought-for meeting is to determine "the acceptability of the clinical protocol and establish the initial clinical efficacy" of the CD-Radiometer. He is hoping for that meeting within the next 30 days and launch of a 450-patient clinical trial within 45 days after winning agency go-ahead.
In other company news, Medi-Photonics is working with Infotonics Technology Center (also Cherry Hill), a research consortium, to develop the Compact Photonic Explorer (CPE), an ingestible "pill camera" for medical and non-medical applications. The corporate partners of Infotonics are Eastman Kodak, Rochester Regional Photonics Cluster (both Rochester, New York) and Xerox (Stamford, Connecticut).
The initial focus of this collaboration is the development of a CPE for detecting detect cancer and monitor body functions. This proof-of-concept research is being led by Alfano and his team at CUNY.