FDA reviews clinical trials for CT laser mammography

The Food and Drug Administration is reviewing a progress report from Imaging Diagnostic Systems about an optical method of diagnostic imaging to find suspicious growths that illuminates the breast with near-infrared light instead of traditional breast compression x-ray.

For six years, Plantation, FL-based Imaging Diagnostic Systems (IMDS) has been developing computed tomography laser mammography. In CTLM, contiguous 4-mm-slice views are reconstructed into a near-three-dimensional view of the breast. Digital display allows computer enhancements to clarify questionable areas within the imaged area.

Because seven of eight breast biopsies come back with normal results, CTLM’s ability to capture a better picture of breasts will cut down the number of women needlessly worrying about cancer and the number of unnecessary costly biopsies, said Richard Grable, CEO of IMDS.

CTLM will help physicians decide whether to recommend further clinical work-ups, he said.

The CTLM scanner sees a tissue change in areas where mammography has revealed calcifications. In imaging the breast, there is a particular size and distribution of calcifications that is highly suggestive of cancer growing, Grable said.

In IMDS’ trials, the patient is given a traditional mammogram first. Then the CTLM acquires the data and the image is reconstructed. The resulting image is compared to the original mammogram, Grable said.

“We are still learning how the CTLM compares to traditional mammography,” Grable said.

This type of scanner can also work with contrast agents traditionally used in MR, CT, and x-ray. CTLM can identify contrast agent indocyanine green (ICG). The lesion’s blood supply absorbs the dye, which is illuminated by the laser scanner.

In the future, ICG may serve as a foundation for fluorescent tags fixed to a group of nascent cancer cells. CTLM will pick up the tags so clinicians can see suspicious areas, Grable said.

With this development, clinicians could detect cancer much earlier. CTLM will help do this with clearer imaging, Grable said. Right now, a woman can detect a 2-cm lump by doing a breast self-exam, while a clinician using traditional mammography can find a 1-cm lump.

A tag that identifies suspicious cells has been the dream of medicine for a long time, Grable said.

Clinical trials were held at Nassau County Medical Center in New York and the University of Virginia’s Breast Center.