CT Software Receives Approval for Quantitative Bone Densitometry Technology

New computed tomography (CT) scanner software has received 510(k) clearance from the US Food and Drug Administration (FDA) to market asynchronous quantitative CT (QCT) calibration technology for CT-based bone mineral density measurement.

Mindways’ (Austin, TX, USA) latest QCT software advance makes it possible to evaluate bone mineral density (BMD) using QCT without the necessity to scan a calibration phantom together with the patient. This mean easier QCT workflow; but, more notably, now any non-intravenous (IV)-contrast abdominal or pelvic CT scan ordered for another reason can be used for additional bone density measurement with no further patient radiation exposure or time.

Mindways’ VP of business development, Alan Brett, PhD, said, “We are very excited about getting this innovative technology into healthcare practice. Because there is a great deal of overlap between patients getting a CT scan and those at risk of bone loss and consequent fragility fractures, the dual-use of CT scans provides for a very efficient method of screening for low bone mass and early identification patients that would benefit from treatment. This is very important because of the catastrophic nature of osteoporotic hip fractures.”

The new technology works by using an earlier acquired calibration scan to transform a CT image into bone mineral density values. In addition to standard CT scans, a successful pilot study has focused on the practicability of a combined CT colonography (CTC) and osteoporosis evaluation screening program. Because patients undergoing CTC screening are typically over the age of 50, they will be at risk of low bone mass, which is a specific concern for postmenopausal women. The dual use of a CTC scan can offer these patients “no-dose” BMD testing without the need to plan a dual-energy X-ray absorptiometry (DXA) test.

The new technology can also offer retrospective analysis of previously acquired images, by interrogating a picture archiving and communication system (PACS) store for CT scans of appropriate patient groups. The new technology will be available sometime in the last quarter of 2014.

Mindways Software, Inc. develops QCT bone densitometry products for spine and hip bone density measurements. The QCT Pro uses QCT images to derive DXA-like to obtain hip BMD measurements and volumetric spine BMD measurements. QCT Pro hip BMD measurements are interpreted in the same manner as DXA and are included in the World Health Organization (WHO; Geneva, Switzerland) FRAX online fracture risk calculator, whereas spine measurements provide excellent sensitivity to short-term bone density changes. QCT Pro is fast, easy to use, and provides the same clinical utility as DXA at less cost.

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