First in-human trial testing 4D mammography is officially underway
The world’s first in-human clinical trial testing the safety and efficacy of 4D mammography is set to ramp up in the United States.
Calidar Inc—a Duke University startup that specializes in diagnostic imaging solutions—announced recently that the first exam using their novel 4D mammography technology had been completed at Baptist Health Hardin, a hospital in Elizabethtown, Kentucky. The hospital will serve as the testing site for the emerging technology, which experts have suggested could be a “pivotal” tool for the future of breast cancer detection.
"This is more than a study milestone — this is the start of a new era of medical imaging," Stefan Stryker, PhD, CEO of Calidar, said in an announcement.
The 4D mammography method harnesses the power of X-ray diffraction and artificial intelligence to interpret molecular signatures of disease. The technique enables the visualization of X-rays scattered by a crystalline material’s crystal lattice. When the X-ray waves are diffracted at different angles within the crystal, their intensities can be measured to identify the presence of unknown substances, gauge cell parameters and spot variability in structure and texture.
In breast cancer settings, X-ray diffraction can help providers identify unique molecular signatures in breast tissue. This latest trial represents the first time the technique has been tested in humans for the detection of breast cancer.
"X-ray diffraction has unlocked some of the most iconic achievements in science—from discovering the structure of DNA to revealing the composition of another world on the Mars rover—and now we are bringing its power into the clinic to look inside the human body in a completely new way,” Stryker continued. “Our 4D Mammography system brings this capability to the challenge of breast cancer diagnostics, where high-precision, noninvasive imaging tools are urgently needed."
The trial is expected to enroll 60 patients who have already had abnormal imaging. It will compare 4D findings to those identified via standard breast imaging methods to determine whether it provides additional diagnostic information of value.
Read more about the technology here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.