Recruiting

Digital Radiography

Sponsor:

Levine, Gary M. , M.D.

Code:

NCT01379092

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trident Specimen Radiography System

Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia

Study Details

Brief summary:

The objective of this study is to evaluate the image quality and operation of a self-contained direct digital radiography system for breast specimen imaging.

Conditions

Breast Cancer

Study ID

NCT01379092

Start date

Jun, 2011

Status verified date

Mar, 2012

Completion date

Jun, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Breast specimens acquired through MIBB or Surgical techniques arriving for specimen imaging

Exclusion Criteria:

  • Breast specimens that are larger than12 x 14 cm.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Breast biopsy specimen imaging & comparison of image quality

Each subject's explanted tissue will serve as both the control (standard analysis) and the experimental analysis of the quality of the images.

Interventions

Trident Specimen Radiography System

MIBB images will be acquired on the standard of care device and the Trident System in the Breast Center at Hoag Hospital. BSS images will be acquired on standard of care device in the Operating Room and/or the Breast Center at Hoag Hospital and then on the Trident System. Image quality will be compared and system operation will be evaluated. Feedback will be provided to manufacturer and the Trident System further refined.

Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia

All the above devices are used for SOC BSS imaging at Hoag Hospital. The images captured from these devices will be compared to the images captured from the Trident Specimen Radiography device.

Primary 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. [ Time Frame: 1 Day ]

Central Contacts and Locations

Central contacts

Gary M. Levine, M.D.

949-764-5780gary.levine@hoag.org

Cheryl M. Hanna, R.N.

949-764-4537cheryl.hanna@hoag.org

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92658

More Information

Sponsor

Levine, Gary M. , M.D.

Last update posted

Mar 16, 2012

Last verified

Mar, 2012

Keywords

  • Radiography
  • Breast Specimen Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Levine, Gary M. , M.D. on 2012-03-16.