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An Evaluation of a Self-contained Direct Digital Radiography System for Breast Specimen Imaging

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

An Evaluation of a Self-contained Direct Digital Radiography System for Breast Specimen Imaging

Specimen imaging is an accepted method for evaluating tissue specimens which are obtained
either through minimally-invasive breast needle biopsy (MIBB) or breast surgery. Specimen
imaging is used to confirm the targeting and sampling adequacy of radiographically apparent
breast abnormalities. Specimen images are acquired and then compared to the routine and
diagnostic imaging to provide radiographic evidence that the index lesion was adequately
targeted and sampled (as in the case of MIBB) or targeted and removed with adequate margins
[as in the case of breast surgical specimens (BSS)]. Specimen imaging also provides guidance
to the histopathologist when evaluating the breast specimen.

Near real-time image acquisition, review and feedback is essential for specimen imaging. The
patient typically remains in compression on the biopsy table for MIBB or under anesthesia
for BSS until the clinician has confirmation that the index abnormality has been adequately
sampled (in the case of MIBB) or surgically excised. For this reason, digital techniques are
favored over analog (film) counterparts because of the immediacy of image acquisition and
transfer and display to the radiologist for review.

Image quality and speed are critical factors in specimen imaging. High resolution images are
a clinical requirement to delineate the features and extent of mass lesions, and presence
and extent of microcalcifications.

Conventional full-field digital (FFDM) mammographic equipment located in the mammography
department is one accepted approach for specimen imaging. An advantage of this method is
that a licensed and skilled mammographic technologist assures the adequate exposure of
specimens. However, this method requires that the FFDM system be free at the time the
specimen arrives in the mammography department, interfering with mammogram schedules. In the
case of BSS, the use of conventional FFDM systems additionally requires the transport of
specimens to the mammography department, adding significant time that the patient is under

Another mode for specimen radiography is self-contained digital radiography specimen imaging
systems that are located in the mammography department or in the Operating Room
(intraoperative). The use of self-contained digital systems frees the conventional
mammography system for its intended purpose, while providing the clinician all the speed of
digital radiography.

It has been shown that intraoperative imaging significantly reduces the amount of time that
the patient is under anesthesia.

Although, self-contained digital radiography specimen imaging systems provide an advantage
in speed, resulting images may suffer in image quality and despite the availability of
intraoperative self contained systems, many clinicians choose to transfer specimens to the
mammography department for imaging on a conventional FFDM system. Current specimen
radiography systems employ an indirect digital technique, a two step conversion, where
incoming x-ray signal is converted to light and then to digital signal. The intermediate
step of converting signal to light, leads to diffusion and scatter over many pixels and this
in turn leads to degradation of the very fine features of mass densities and

Direct Digital technique is another method currently used in breast imaging. The direct
digital technique has the advantage of converting incoming signal directly to digital
signal, avoiding the intermediary light conversion phase of indirect exposure. The direct to
digital process results in better use of incoming signal and greater resolution and thus a
sharper image, providing high resolution of minute features associated with mass lesions and

Another common characteristic of current self-contained systems is the use of "stitching"
many small CMOS chips to create a larger image detector. This type of tiling provides for a
more economical system, but shearing effects, gaps between chips and overall concerns with
calibration of multiple chips significantly degrades image quality.

All digital images, indirect or direct are acquired in a raw state and processed to allow
review. While image processing cannot improve or change the raw aspects of the image after
acquisition, processing can improve the visibility of features available in the image. Image
processing is fundamentally associated with image acquisition technique. If the image is not
adequately exposed, image processing will not be optimally applied and in some cases fail,
requiring additional imaging.

Inclusion Criteria:

- Breast specimens acquired through MIBB or Surgical techniques arriving for specimen

Exclusion Criteria:

- Breast specimens that are larger than12 x 14 cm.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Breast biopsy specimen will be imaged on standard of care device and on the Trident Specimen Radiography device to compare quality of images.

Outcome Description:

Images will be taken at time of biopsy with no additional follow-up time for patient.

Outcome Time Frame:

1 Day

Safety Issue:


Principal Investigator

Gary M. Levine, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hoag Memorial Hospital Presbyterian


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

June 2012

Related Keywords:

  • Breast Cancer
  • Radiography
  • Breast Specimen Imaging
  • Breast Neoplasms



Hoag Memorial Hospital Presbyterian Newport Beach, California  92658