NCT01379092

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

June 2, 2011

Last Update Submit

March 15, 2012

Conditions

Breast Cancer

Keywords

RadiographyBreast Specimen Imaging

Outcome Measures

Primary Outcomes (1)

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

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

    1 Day

Secondary Outcomes (1)

  • Device Operation

    1 Day

Study Arms (1)

Breast biopsy specimen imaging & comparison of image quality

EXPERIMENTAL

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

Device: Trident Specimen Radiography SystemDevice: Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia

Interventions

Trident Specimen Radiography SystemDEVICE

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.

Breast biopsy specimen imaging & comparison of image quality
Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) SeleniaDEVICE

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.

Breast biopsy specimen imaging & comparison of image quality

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Breast specimens that are larger than12 x 14 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

RECRUITING

Related Publications (2)

  • Silverstein MJ, Lagios MD, Recht A, Allred DC, Harms SE, Holland R, Holmes DR, Hughes LL, Jackman RJ, Julian TB, Kuerer HM, Mabry HC, McCready DR, McMasters KM, Page DL, Parker SH, Pass HA, Pegram M, Rubin E, Stavros AT, Tripathy D, Vicini F, Whitworth PW. Image-detected breast cancer: state of the art diagnosis and treatment. J Am Coll Surg. 2005 Oct;201(4):586-97. doi: 10.1016/j.jamcollsurg.2005.05.032. No abstract available.

    PMID: 16183499BACKGROUND

  • Kaufman CS, Jacobson L, Bachman BA, Kaufman LB, Mahon C, Gambrell LJ, Seymour R, Briscoe J, Aulisio K, Cunningham A, Opstad F, Schnell N, Robertson J, Oliver L. Intraoperative digital specimen mammography: rapid, accurate results expedite surgery. Ann Surg Oncol. 2007 Apr;14(4):1478-85. doi: 10.1245/s10434-006-9126-5. Epub 2007 Jan 18.

    PMID: 17235716BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gary M. Levine, M.D.

    Hoag Memorial Hospital Presbyterian

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary M. Levine, M.D.

CONTACT

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

Cheryl M. Hanna, R.N.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Breast Imaging

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

US(1)