Cancer Diagnosis Technique gets FDA clearance

Thanks to a diagnostic imaging technique that should soon be finding its way to medical establishments, many patients could be spared the pain and risk of biopsies. The technique, called 3TP, has recently received FDA clearance for use in the detection of breast and prostate cancer, and is slated for distribution as early as next year. It will enable doctors to distinguish between malignant tumors and benign lumps by scanning instead of cutting.  

3TP (Three Time Point) makes use of existing MRI scanners, and a safe contrast agent that is injected into the patient. The suspected tumor site is scanned by MRI repeatedly over a period of several minutes. The software developed for the method analyzes three of the MRI images, one before and two after the injection (hence the name 3TP), and then creates a colored likeness of the breast or prostate area based on the resulting data. A preponderance of red in the picture indicates malignancy, while mainly blue and green are signs of a benign growth.

The procedure, developed by Prof. Hadassa Degani and her research group at the Weizmann Institute of Science Biological Regulation Dept., arose from her research on the development of cancerous tumors. Typically, malignancies, which need a steady supply of oxygen and nutrients in order to grow, contain many small, new blood vessels. Blood flow in and out of the area of the tumor is usually accelerated. Tumor cells are distributed unevenly, with areas of densely packed cells that have tighter between-cell spaces than normal.

In order to obtain the 3TP image, the contrast agent, which enhances the MRI images, is injected into the bloodstream, and the flow of the agent into the area being scanned is traced. The agent, which quickly passes through the blood, will enter and clear out of a cancerous tumor faster, and contrast agent escaping vessel walls (new blood vessels tend to leak) will be highlighted, along with the spaces between cells. By making calculations based on comparisons between the images, the software can assign a color to each tiny pixel making up the graphic image.

Several hospitals in the U.S. have participated in the clinical trials, testing hundreds of patients who were slated to undergo biopsies. The 3TP scans were sent to Degani’s lab in Israel for analysis, and her diagnoses were later compared with the results of the biopsies. Tests were conducted in such a way that Degani knew nothing about the patient’s medical history, thus her results were based solely on the 3TP image.  Doctors, as well, did not see the 3TP results until they had reached a diagnosis through biopsy. In impressive trial results, solid growths larger than five millimeters (1/5 inch) were diagnosed correctly using 3TP nearly 100% of the time. For all trials, including patients with DCIS (a non-invasive, non-lump-forming cancer in the milk ducts), the accuracy rate was close to 90%.

While others have come up with various methods of diagnosing cancer using MRI technology, Degani emphasizes that the 3TP technique is the only one that provides an accurate, standardized system that any clinician can easily use. The speed with which results can be obtained and the prevention of unnecessary biopsies will make it cost-effective as well. The procedure is likely to be used in the future to diagnose a variety of cancers and, while it is moving from the trial stages to clinical use on breast and prostate, research is starting on the lungs. In addition, more research will be done on using 3TP scanning to track the response of tumors to anti-cancer therapies.

The method will be distributed by a U.S. company called 3TP LLC.  In operation a little over a year, it was founded to market the 3TP technology, to which it received worldwide rights through Yeda, the commercial arm of the Weizmann Institute.  Because 3TP is non-invasive, and is based on existing MRI technology, the FDA clearing process was shorter than expected. Now the company, presently engaged in beta-testing of its product in six American medical institutions, is seeking clearance in Canada and Europe.  3TP LLC can be contacted at (1) 631-702-2400; JRM3TP@hamptons.com.

Prof. Hadassa Degani's research is supported by Sir David Alliance, CBE, UK; M.D. Moross Institute for Cancer Research; Mr. and Mrs. Lon Morton, Calabasas, CA; Mrs. Jackie Gee, Ms. Livia Meyer and Mr. Harry Woolf, UK; Ms. Lynne Mochon and Ms. Edith Degani, NY, USA; The Washington Square Health Foundation; Willner Family Center for Vascular Biology; and The Estate of Mrs. Ilse Katz, Switzerland.

Prof. Degani is the incumbent of the Fred and Andrea Fallek Professorial Chair in Breast Cancer Research.

The Weizmann Institute of Science in Rehovot, Israel is one of the world's top-ranking multidisciplinary research institutions. Noted for its wide-ranging exploration of the natural and exact sciences, the Institute is home to 2,500 scientists, students, technicians and supporting staff. Institute research efforts include the search for new ways of fighting disease and hunger, examining leading questions in mathematics and computer science, probing the physics of matter and the universe, creating novel materials and developing new strategies for protecting the environment.