New procedure could replace breast biopsies

SOUTH BEND, Ind.--- Around 1.7 million women have a breast biopsy each year. It's an invasive, painful and costly test that comes back negative more than half of the time.

Now, there's a different way to tell if a mass is cancerous.

The best part? No needle required!

Whether playing hide & seek or piano, when 3 yr. old Kadin is around grandma Roz is always playing something.

"I am blessed by all my grandchildren, but this one's got me," says Roz Sobel

She's needed the distraction.

A few months ago-doctors found a lump on Sobel’s mammogram. It was a scary moment for a woman whose mother, grandmother, sister, cousin and niece all had breast cancer.

"My family has a horrible history," said Sobel.

Typically women like Sobel will need a painful needle biopsy to determine if the lump is cancerous, but she took part in a clinical trial testing a new technology called Opto-Acoustics.

"The thought is that this will help us determine what is cancer and what is not cancer," said Paulette Lebda, MD, a Breast Radiologist at The Cleveland Clinic.

With the Opto-Acoustics technology, there's no radiation, no needle, no pain, and no risk to the patient.

An ultrasound with a laser is used to look at the distribution of oxygenated and deoxygenated blood in the lump. It's essentially a blood map for doctors.

"Usually, benign breast masses can have a different blood profile, or blood map, than cancerous masses,” said Lebda

Studies have shown the technique could reduce the number of biopsies by 40 percent, which was music to Sobel’s ears.

It turned out her lump was caused by a dog jumping on her, not cancer.

"They knew right then and there that it was from the dog," said Sobel

Opto-acoustics is currently in being studied in a clinical trial, at 16 centers around the country.

It won't replace mammograms, but may decrease the need for invasive biopsies by separating cancerous and non-cancerous masses through imaging.

REPORT #2084

BACKGROUND: Imaging techniques, like a MRI or a mammogram, along with physical exams of the breast can lead doctors to suspect that a person has breast cancer. However, the only way to know for sure is to take a sample of tissue from the suspicious area, called a biopsy. Usually, if the doctor notices anything suspicious he or she will order a biopsy. The tissue sample is examined by a pathologist to see if cancer cells are present or not. (Source:
HOW IT IS DONE: There are several ways to do a breast biopsy, including:

* Fine-needle aspiration biopsy: the doctor inserts a thin needle into a lump and removes a sample of cells or fluid.
* Core needle biopsy: the doctor inserts a needle with a special tip and removes a sample of breast tissue about the size of a grain of rice.
* Open (surgical) biopsy: the doctor will make a small cut in the skin and breast tissue to remove part or all of a lump. This may be done as a first step to check a lump or if a needle biopsy does not provide enough information.
* Vacuum-assisted core biopsy: this is performed with a probe that uses a gentle vacuum to remove the breast tissue sample. The small cut does not require stitches and leaves a very small scar. (Source:

OPTOACOUSTIC TECHNIQUE: The Cleveland Clinic, along with 15 other sites across the country, are testing a new technique that could cut down on the number of invasive breast biopsies. Almost two million women in the U.S. undergo a needle or surgical biopsy every year, and about 60 percent of the masses are non-cancerous. The trial (PIONEER-01 trial) is designed to gauge the effectiveness of Imagio (an imaging device), which combines ultrasound with opto-acoustics, an imaging technology based on sound and light. Imagio doesn't require radiation from X-ray, or contrast agents injected into a person's bloodstream, to get the high-resolution images that researchers say can distinguish if a breast mass is cancerous. The device is a handheld probe that moves along the surface of the skin to pick up signals. The process takes about 15 minutes. The opto-acoustic technique shows the presence of blood vessel networks. The vessels that grow around cancerous tissue are filled with oxygen or have very little oxygen in them. If the suspicious tissue mass doesn't have any of those characteristics, then the mass is more likely to be non-cancerous. If the device gets FDA approval based on results of the PIONEER-01 trial, then researchers believe it will be at least a couple of years before Imagio is available for clinical use. For more information on enrolling, go to: (Source: The Cleveland Clinic and
? For More Information, Contact:

Andrea Pacetti
Media Relations Manager
The Cleveland Clinic

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