NCT00807404

Brief Summary

RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells. PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

2.3 years

First QC Date

December 10, 2008

Last Update Submit

May 26, 2010

Conditions

Precancerous Condition

Keywords

ductal intraepithelial neoplasia

Outcome Measures

Primary Outcomes (3)

  • Design of a portable forward imaging optical coherence tomography (OCT) needle probe

  • Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology

  • Development of an OCT needle probe that is capable of acquiring core biopsy samples

Interventions

histopathologic examinationPROCEDURE
optical coherence tomographyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia PATIENT CHARACTERISTICS: * Fertile and/or pregnant patients allowed PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Precancerous Conditions

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • I. B. Paz, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

November 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

US(1)