NCT00734838

Brief Summary

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable breast-cancer

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

January 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2022

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

16.8 years

First QC Date

August 13, 2008

Last Update Submit

August 10, 2023

Conditions

Breast Cancer

Keywords

Breast CancerBreast BiopsyReduction mammoplasty

Outcome Measures

Primary Outcomes (1)

  • Optical signatures

    The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast

    Day of procedure (less than 10 minutes)

Study Arms (2)

Core needle biopsy

EXPERIMENTAL

Patients needing a needle biopsy of a breast mass

Device: High Resolution Microendoscope

Reduction mammoplasty

PLACEBO COMPARATOR

Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer

Device: High Resolution Microendoscope

Interventions

High Resolution MicroendoscopeDEVICE

Using core biopsy and reduction mammoplasty tissue

Core needle biopsyReduction mammoplasty

Eligibility Criteria

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

You may qualify if:

  • Patients having a needle biopsy of a breast mass

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nimmi Ramanujam, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

January 1, 2006

Primary Completion

October 3, 2022

Study Completion

October 3, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

US(1)