Why the Gold Standard Mammogram Isn't Good Enough

Mammography remains the only imaging modality with FDA approval for breast cancer screening. And yet, "mammography still misses cancers today," says Dinu. A false negative on a mammogram is read as normal despite cancer being present. One major contributor to false negatives is breast density—about 40% of women have dense breast tissue, a limitation that 3D ultrasound directly targets. Dense tissue appears white on a mammogram, the same color as cancer, making tumors difficult to spot. This limitation helps explain why cancers can be harder to detect in dense breast tissue, which is also an independent risk factor for the disease. Women with dense breast tissue typically turn to MRI for follow-up, but it is expensive, requires contrast injection, and demands specialized radiologists to interpret. Women with dense tissue can also follow-up with a handheld ultrasound exam by a credentialed sonographer. However, access to trained personnel limits this approach. "60 to 70% of women today are in this middle, intermediate-risk group," Dinu says — a group for whom there is, according to the U.S. Preventive Services Task Force, no formal recommendation for or against additional screening with MRI or ultrasound.

What does 3D Ultrasound Offer to Patients

Unlike mammography, which compresses breast tissue and uses radiation, MRI, which requires contrast injection and specialized radiologists, or handheld ultrasound, which is performed by a sonographer, a 3D ultrasound scanner uses sound waves to create a three-dimensional image. There is no compression, no radiation, no contrast.

The scanning process itself is markedly different from both mammography and traditional ultrasound. The patient lies face down on a padded table and places one breast at a time into a tank of warm, chlorinated water. From there, a ring of transducers rotates around the breast, capturing coronal slices every two millimeters from the chest wall to the nipple, about 60 slices for an average-sized breast. The result is a fully reconstructed 3D image of the breast tissue. "The technologist doesn’t have to be a highly trained sonographer or mammographer,” says Misra. In some centers, the role is filled by medical assistants, a deliberate design choice that addresses one of traditional ultrasound’s biggest limitations: operator dependency. The full scan takes between 20 and 30 minutes and has been validated for women from cup size A through triple D.

Does 3D Ultrasound Work? The Clinical Data Is Encouraging

Of course, feasibility alone isn’t enough as accuracy is what ultimately matters. Clinical validation is the cornerstone of QT Imaging’s current strategy — and their early results are garnering attention, though the full picture is still emerging.

In a preliminary head-to-head study conducted with Mayo Clinic, QT Imaging’s scanner detected every finding identified by MRI, according to Dinu. In one notable case, the modalities disagreed: MRI classified a patient as BI-RADS 4 (suspicious), while the QT scan rated her BI-RADS 3 (probably benign). Biopsy later confirmed the QT assessment. "We are going to get fewer women to unnecessary biopsies," says Dinu — though she cautions that larger sample sizes will be needed to draw firmer conclusions about false positive rates.

Early findings also suggest the technology may offer capabilities that differ from MRI. QT’s speed-of-sound imaging can detect calcifications, something MRI does not reliably detect, and distinguishes cysts from solid masses with high precision. The scanner additionally calculates breast density automatically, without the third-party processing currently required in mammography.

Perhaps most intriguing is its potential as a surveillance tool. Because QT involves no radiation or contrast agents, it can theoretically be repeated frequently and safely. Ongoing research at Toronto's Sunnybrook Health Sciences Centre is exploring its use for monitoring tumor response in patients undergoing chemotherapy — a context where repeated MRIs or mammograms would raise concerns about cumulative contrast load or radiation exposure. That research, like the Mayo Clinic work, remains ongoing.

Studies with Mayo Clinic and Sunnybrook are ongoing, with Stanford next. Early results are consistent, but sample sizes remain limited and peer-reviewed publication will be essential before the technology can be broadly validated. "We keep comparing ourselves head-to-head with MRI and showing again and again that the sensitivity and specificity are there," says Dinu. "There is no shortcut. We have to keep showing."

Getting a QT Scan: What Patients Need to Know

As with many emerging technologies, availability and cost remain key considerations. Right now, QT imaging is considered by Dinu and Misra a supplement to the gold standard mammogram. They emphasize that patients should not use QT imaging to replace their screening mammogram, but rather as a tool, especially those with dense breast tissue, to get additional screening.

For women interested in pursuing a QT scan, the process is more straightforward than many imaging procedures. No physician referral is required — patients can book directly at independent imaging centers. For women navigating an increasingly complicated screening landscape, the ability to self-refer is a meaningful option.

The main barrier right now is cost. Scans run between $600 and $700 out of pocket, and insurance does not yet cover the procedure, though providers can utilize existing unlisted codes. This cost, if it remains, could widen gaps in screening, particularly for lower-income and under-resourced communities. However, Misra notes that QT Imaging recently secured a Category III reimbursement code — the first formal step toward full insurance coverage— which goes into effect January 1, 2027.

"It’s a process," says Misra, but the company plans to begin working with payers immediately to push toward fair reimbursement rates. Category III codes function as tracking mechanisms, allowing insurers to monitor utilization before committing to full coverage; once that threshold is met, the code can be elevated to Category I — the standard used for established, routinely reimbursed procedures.

For now, QT remains an out-of-pocket option for women who can afford it and are looking for a more complete picture.