Nuclear cardiac market is facing increasing constraints on patient exposure to
radiation and radioisotope availability, coupled with growing demand on patient
comfort and imaging outcomes.
The aim of this document is to outline clinically proven imaging alternatives
using the FDA-cleared and CE Mark-approved UltraSPECT products to accommodate
each of these constraints and demands- separately or jointly; the products,
installed in over 250 NM sites worldwide, allow the utilization of lower dose
imaging protocols with no compromise in imaging acquisition times and outcomes,
reducing patient radiation exposure, while at the same time overcome any
periodic Technetium shortage.
UltraSPECT utilizes proprietary
WBR image reconstruction technology for cardiac and
bone applications. These products improve image quality and diagnostic
efficacy, doubling the NEMA standard resolution for the currently installed
camera systems. This improvement allows the reduction of scan times to one
half-time or a
quarter-time of the currently approved protocols, thereby enhancing
clinical productivity and improving patient comfort. Moreover, UltraSPECT
products are cleared to allow clinical protocols enabling
reduced injection doses, thus ensuring a steadier delivery of the
existing Tc-99m supplies while minimizing patient exposure to radiation.
UltraSPECT WBR reconstruction presents the physician with a set of high-quality
images which provide, according to a large number of peer-reviewed articles in
professional journals and presentations at professional conferences, higher
clinical efficacy.
As of today, UltraSPECT provides connectivity to the imaging systems of all
three major NM camera manufacturers, supporting most existing camera hardware
and workstation versions.
UltraSPECT's FDA-Cleared and CE Mark-Approved Dose-Saving
Protocols:
A. The
Xpress.CardiacTM product
Half-Dose, Half-Time Single-Day Rest/Stress Protocol
Applying the one-day Tc-99m Rest/Stress protocol with scan times as defined by
the ASNC recommendations, but with injected doses that are approximately half
the doses specified by ASNC:
Rest: 5-6 mCi; 8-9 mCi for patients weighing >100 kg.
Stress: 15-20 mCi; 24-27 mCi for patients weighing >100 kg.
B. The
Xpress3.CardiacTM Product
1. Half-Dose, Half-Time Single-Day Rest/Stress Protocol
As suggested by its name, the half-dose, half-time Tc-99m Rest/Stress protocol
combines reduced injection doses with shortened scan times, enabling higher
patient safety and comfort, while helping overcome the impact of radioisotope
supply shortages and increasing patient throughput. A typical "half-dose
half-time" same-day Tc-99m Rest/Stress protocol consists of:
Rest: 5-6 mCi; 15-20 sec. per stop.
Stress: 15-20 mCi; 10 sec per stop.
Note:
However, as in other protocols involving a shorter acquisition time, caution
should be exercised when scanning larger patients. In patients with large chest
circumferences and in women with large, dense breasts, doses should be
increased proportionately for both the Rest and Stress scans, or the two-day
Stress/Rest half-dose half-time scan protocol should be applied.
2. Dual-Isotope Single-Day Protocol
The one-day dual-isotope Tl-201/Tc-99m protocol combines reduced doses and
shorter scan times. Reduced-dose shorter-time Rest Tl-201 imaging is followed
by shorter-time reduced-dose Tc-99m Stress imaging:
Rest: Tl-201, 2 mCi (female) / 3 mCi (male); 20sec. per stop.
Stress: Tc-99m, 20 mCi (female) / 30 mCi (male); 10sec. per stop.
As attested by many users of dose-reduction protocols enabled by UltraSPECT's
image reconstruction products, the negative impact of the reactor shutdowns can
be substantially mitigated, freeing up Tc-99m supplies to accommodate all their
patients.
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